National Collaborating Centre for Women's and Children's Health
Antenatal care
routine care for the healthy pregnant woman
Clinical Guideline
March 2008
Funded to produce guidelines for the NHS by NICE
Antenatal care
routine care for the healthy pregnant woman
National Collaborating Centre for Women's and Children's Health Commissioned by the National Institute for Health and Clinical Excellence
March 2008
This is a partial update of the 2003 guideline. New or amended sections are indicated by a grey bar in the margin.
RCOG Press
Published by the RCOG Press at the Royal College of Obstetricians and Gynaecologists, 27 Sussex Place, Regent's Park, London NW1 4RG www.rcog.org.uk Registered charity no. 213280 First published 2008, revised reprint 2008 (page 98) 2nd edition 2008 National Collaborating Centre for Women's and Children's Health 1st edition published in 2003 No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK [www.cla.co.uk]. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use. While every effort has been made to ensure the accuracy of the information contained within this publication, the publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check current indications and accuracy by consulting other pharmaceutical literature and following the guidelines laid down by the manufacturers of specific products and the relevant authorities in the country in which they are practising. ISBN 978-1-904752-46-2 NCC-WCH Editor: Andrew Welsh Original design: FiSH Books, London Typesetting: Andrew Welsh Proofreading: Katharine Timberlake (Reedmace Editing) Index: Jan Ross (Merrall-Ross (Wales) Ltd) Printed by Henry Ling Ltd, The Dorset Press, Dorchester DT1 1HD
Contents
Guideline Development Group membership and acknowledgements Original (2003) version: Guideline Development Group Acknowledgments Stakeholder organisations Peer reviewers 2008 update: Guideline Development Group Acknowledgments Stakeholder organisations Abbreviations Glossary of terms 1 Introduction 1.0 Introduction 1.1 Aim of the guideline 1.2 Areas outside the remit of the guideline 1.3 For whom is the guideline intended 1.4 Who has developed the guideline 1.5 Who has developed the guideline update 1.6 Guideline methodology 2 Summary of recommendations and care pathway 2.1 Key priorities for implementation (key recommendations) 2.2 Summary of recommendations 2.3 Key priorities for research 2.4 Additional research recommendations 2.5 Care pathway 3 Woman-centred care and informed decision making 3.1 Introduction 3.2 Provision of information 3.3 Antenatal classes 4 Provision and organisation of care 4.1 Who provides care 4.2 Continuity of care 4.3 Where should antenatal appointments take place 4.4 Documentation of care 4.5 Frequency of antenatal appointments 4.6 Gestational age assessment 4.7 What should happen at antenatal appointments 5 Lifestyle considerations 5.1 Physiological, psychosocial and emotional changes in pregnancy 5.2 Maternity health benefits 5.3 Working during pregnancy 5.4 Dietary information and education 5.5 Nutritional supplements 5.6 Food-acquired infections 5.7 Prescribed medicines 5.8 Over-the-counter medicines 5.9 Complementary therapies 5.10 Exercise in pregnancy 5.11 Sexual intercourse in pregnancy 5.12 Alcohol and smoking in pregnancy 5.13 Cannabis use in pregnancy 5.14 Air travel during pregnancy 5.15 Car travel during pregnancy 5.16 Travelling abroad during pregnancy vi vi vi vi vii viii viii viii xii xvi 1 1 1 2 3 3 3 4 12 12 13 25 26 27 37 37 37 58 67 67 67 69 69 70 73 78 82 82 82 82 83 84 92 93 93 93 94 95 95 101 101 102 103
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6 Management of common symptoms of pregnancy 6.1 Nausea and vomiting in early pregnancy 6.2 Heartburn 6.3 Constipation 6.4 Haemorrhoids 6.5 Varicose veins 6.6 Vaginal discharge 6.7 Backache 6.8 Symphysis pubis dysfunction 6.9 Carpal tunnel syndrome 7 Clinical examination of pregnant women 7.1 Measurement of weight and body mass index 7.2 Breast examination 7.3 Pelvic examination 7.4 Female genital mutilation 7.5 Domestic violence 7.6 Psychiatric screening 8 Screening for haematological problems 8.1 Anaemia 8.2 Blood grouping and red cell alloantibodies 8.3 Screening for haemoglobinopathies (sickle cell disease and thalassaemia) 9 Screening for fetal anomalies 9.1 Screening for structural anomalies 9.2 Screening for Down's syndrome 10 Screening for infections 10.1 Asymptomatic bacteriuria 10.2 Asymptomatic bacterial vaginosis 10.3 Chlamydia trachomatis 10.4 Cytomegalovirus 10.5 Hepatitis B virus 10.6 Hepatitis C virus 10.7 HIV 10.8 Rubella 10.9 Streptococcus group B 10.10 Syphilis 10.11 Toxoplasmosis 11 Screening for clinical problems 11.1 Gestational diabetes 11.2 Pre-eclampsia 11.3 Preterm birth 11.4 Placenta praevia 12 Fetal growth and wellbeing 12.1 Introduction and background 12.2 Diagnostic value for predicting SGA babies 12.3 Diagnostic value for predicting LGA babies 12.4 Effectiveness studies 12.5 Health economics evidence 12.6 Fetal wellbeing 13 Management of specific clinical conditions 13.1 Pregnancy after 41 weeks 13.2 Pregnancy after 42 weeks 13.3 Breech presentation at term 14 Antenatal assessment tool 14.1 Introduction and background 14.2 Systematic review of the evidence 14.3 Developing an antenatal assessment tool Appendix A Declarations of interest Appendix B Economic model: asymptomatic bacteriuria screening programme Appendix C Economic model: streptococcus group B screening programme Appendix D Economic model: syphilis screening programme
106 106 108 109 110 110 111 112 113 113 114 114 115 115 116 117 118 120 120 121 122 134 134 154 180 180 183 184 193 194 194 195 197 198 200 202 205 205 218 228 251 253 253 255 265 267 274 275 278 278 279 280 282 282 282 286 290 292 294 295
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Appendix E Economic model: screening for congenital cardiac malformations Appendix F Economic model: screening and treatment of gestational diabetes Appendix G Economic model: monitoring fetal growth Appendix H Training and equipment standards for ultrasound screening in pregnancy Appendix I Further information Appendix J Family origin questionnaire Appendix K Deleted material from the 2003 version 2.1 Summary of recommendations 2.3 Algorithm – Antenatal care: routine care for the healthy pregnant woman 3.1 Provision of information 3.2 Antenatal education 4.6 Gestational age assessment: LMP and ultrasound 5.5 Nutritional supplements 5.12 Alcohol and smoking in pregnancy 8.2 Screening for sickle cell disorders and thalassaemia 9 Screening for fetal anomalies 9.1 Screening for structural anomalies 9.2 Screening for Down's syndrome 10.1 Asymptomatic bacteriuria 10.3 Chlamydia trachomatis 11.1 Gestational diabetes mellitus 11.2 Pre-eclampsia 11.3 Preterm birth 11.4 Placenta praevia 12.2 Measurement of symphysis–fundal distance 12.7 Umbilical and uterine artery Doppler ultrasound 15 Auditable standards Appendix 1 References (2003 version) References (2008 update) Index Search strategies Excluded studies Evidence tables
297 305 331 336 337 338 339 339 341 344 345 347 348 348 349 350 351 353 357 357 358 361 364 365 365 366 368 369 380 397 408 CD-ROM CD-ROM CD-ROM
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Guideline Development Group membership and acknowledgements
Original (2003) version
Guideline Development Group
Peter Brocklehurst Belinda Ackerman Brian Cook Joanie Dimavicius Helen Edwards Gill Gyte Shahid Husain Gwyneth Lewis Tim Overton Gill Roberts Stephen Robson Julia Sanders Anne White Jane Thomas Sue Lee Jennifer Gray Natalie Terry Hannah Rose Douglas Dimitra Lambrelli Group Leader Midwife General Practitioner Consumer Radiographer Consumer Neonatologist Confidential Enquiry into Maternal Deaths Obstetrician RCOG Patient Information Specialist Obstetrician Midwife General Practitioner Director NCC-WCH Research Fellow NCC-WCH Informatics Specialist NCC-WCH Administrative support NCC-WCH Health Economist, London School of Hygiene and Tropical Medicine Health Economist London School of Hygiene and Tropical Medicine
Acknowledgments
Additional support was also received from: David Asomani, Anna Burt, Heather Brown, Susan Davidson, Gregory Eliovson, Susan Murray and Alex McNeil at the National Collaborating Centre for Women's and Children's Health. Stravros Petrou at the National Perinatal Epidemiology Unit and Kirsten Duckitt at the John Radcliffe Hospital, Oxford. Members of the previous Antenatal Care Guideline Development Group: John Spencer (Chairman), J Bradley, Jean Chapple, R Cranna, Marion Hall, Marcia Kelson, Catherine McCormack, Ralph Settatree, Lindsay Smith, L Turner, Martin Whittle, Julie Wray. The Patient Involvement Unit, whose glossary we have amended for use in this guideline. The Three Centres Consensus Guidelines on Antenatal Care, Mercy Hospital for Women, Monash Medical Centre (Southern Health) and The Royal Women's Hospital (Women's & Children's Health), Melbourne 2001, whose work we benefited from in the development of this guideline.
Stakeholder organisations
Action on Pre-Eclampsia (APEC) Antenatal Results and Choices Association for Continence Advice (ACA) Association for Improvements in Maternity Services (AIMS) vi
Guideline Development Group membership and acknowledgements
Association of Radical Midwives Association of the British Pharmaceuticals Industry(ABPI) Aventis Pasteur MSD Brighton Healthcare NHS Trust British Association of Paediatric Surgeons British Association of Perinatal Medicine British Dietetic Association British Maternal and Fetal Medicine Society British Medical Association British National Formulary British Psychological Society BUPA Chartered Society of Physiotherapy CIS'ters Department of Health Evidence based Midwifery Network Faculty of Public Health Medicine Gateshead Primary Care Trust General Medical Council Group B Strep Support Health Development Agency Hospital Infection Society Isabel Medical Charity Maternity Alliance Mental Health Foundation Monmouthshire Local Health Group National Childbirth Trust NHS Quality Improvement Scotland Nottingham City Hospital Obstetric Anaesthetists Association Royal College of General Practitioners Royal College of General Practitioners Wales Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Psychiatrists Royal College of Radiologists Royal Pharmaceutical Society of Great Britain Royal Society of Medicine Scottish Intercollegiate Guidelines Network (SIGN) Sickle Cell Society Society and College of Radiographers STEPS Survivors Trust Twins and Multiple Births Association (TAMBA) UK Coalition of People Living with HIV and AIDS UK National Screening Committee UK Pain Society United Kingdom Association of Sonographers Victim Support Welsh Assembly Government (formerly National Assembly for Wales) West Gloucestershire Primary Care Trust Young Minds
Peer reviewers
Susan Bewley, Leanne Bricker, Howard Cuckle, Andrew Dawson, Viv Dickinson, Grace Edwards, Jason Gardosi, Duncan Irons, Deirdre Murphy, Tim Reynolds, Jilly Rosser, Lindsay Smith, John Spencer, Pat Tookey, Derek Tuffnell, Gavin Young. vii
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Guideline Development Group
GDG members
Rhona Hughes Jane Anderson Chris Barry Marie Benton Jennifer Elliott Nina Khazaezadeh Rachel Knowles Tim Overton Katie Yiannouzis Group Leader Ultrasound Radiographer General Practitioner Service User Representative Service User Representative Consultant Midwife and Supervisor of Midwives Medical Research Council Clinical Public Health Research Fellow Consultant Obstetrician Head of Midwifery
National Collaborating Centre for Women's and Children's Health (NCC-WCH) staff
Rupert Franklin Eva Gautam-Aitken Paul Jacklin Rajesh Khanna Rintaro Mori Francesco Moscone Debbie Pledge Jeff Round Anuradha Sekhri Roz Ullman Martin Whittle Work-Programme Coordinator Work-Programme Coordinator Senior Health Economist Senior Research Fellow Research Fellow Health Economist Senior Information Scientist Health Economist Research Fellow Senior Research Fellow Co-Director in Women's Health
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External advisers
Guy Rooney Anne Longton Fiona Ford Jane Hawdon Genitourinary Medicine Specialist Health Visitor Dietician Consultant Neonataologist
Acknowledgments
Additional support was also received from: Anna Bancsi, Angela Kraut, Moira Mugglestone and Martin Dougherty at the NCC-WCH Allison Streetly, Programme Director for the NHS Sickle Cell and Thalassaemia Screening Programme. Andrew Welsh, freelance guideline editor, whose editorial support was invaluable in the production of this guideline. Group Dynamics, who provided the voting equipment for the Assessment Tool consensus meeting.
Stakeholder organisations
Academic Division of Midwifery, University of Nottingham Action on Pre-Eclampsia Addenbrooke's NHS Trust All Wales Birth Centre Group Antenatal Screening Wales Association for Psychoanalytic Psychotherapy in the NHS Association for Spina Bifida & Hydrocephalus (ASBAH) Association of Breastfeeding Mothers Association of British Clinical Diabetologists Association of Chartered Physiotherapists in Women's Health viii
Guideline Development Group membership and acknowledgements
Association of Medical Microbiologists Association of the British Pharmaceuticals Industry (ABPI) Baby Lifeline Barnsley Acute Trust Barnsley PCT BDF Newlife (Birth Defects Foundation) Bedfont Scientific Ltd Bedfordshire PCT Berkshire Healthcare NHS Trust Birmingham Women's Healthcare Trust Birth Trauma Association Bradford & Airedale PCT Bradford Teaching Hospitals NHS Foundation Trust Brighton & Sussex University Hospitals Trust Bristol Health Services Plan British Association for Counselling and Psychotherapy British Dietetic Association British HIV Association (BHIVA) British Hypertension Society British Maternal and Fetal Medicine Society British National Formulary (BNF) British Psychological Society Calderdale PCT CASPE CEMACH Chartered Society of Physiotherapy Chelsea & Westminster NHS Foundation Trust Chronic Conditions Collaborating Centre CIS'ters CO-Awareness Commission for Social Care Inspection Community Practitioners and Health Visitors Association Connecting for Health Cotswold and Vale PCT Croydon PCT Cytyc UK Ltd Department of Health, Social Security and Public Safety of Northern Ireland Derbyshire Mental Health Services NHS Trust Det Norske Veritas – NHSLA Schemes Doula UK Down's Syndrome Association Dudley Group of Hospitals NHS Trust English National Forum of LSA Midwifery Officers Epsom & St Helier University Hospitals NHS Trust Evidence-based Midwifery Network Faculty of Family Planning and Reproductive Health Care Faculty of Public Health Foundation for the Study of Infant Deaths Gateshead PCT Gloucestershire Acute Trust Gloucestershire Hospitals NHS Foundation Trust Group B Strep Support Guy's and St Thomas' NHS Foundation Trust Health Protection Agency Healthcare Commission Homerton University Hospital NHS Foundation Trust Huntleigh Healthcare King's College Hospital NHS Trust
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Liverpool PCT Liverpool Women's Hospital NHS Trust Luton and Dunstable Hospital NHS Trust Mast Diagnostics Medicines and Healthcare products Regulatory Agency (MHRA) Mid and West Regional MSLC Milton Keynes PCT Monica Healthcare Ltd MRC Centre of Epidemiology for Child Health National Childbirth Trust National Chlamydia Screening Programme National Patient Safety Agency National Public Health Service – Wales NHS Direct NHS Health and Social Care Information Centre NHS Quality Improvement Scotland NHS Sickle Cell and Thalassemia Screening Programme North Tees and Hartlepool NHS Trust Northwest London Hospitals NHS Trust Nutrition Society Obstetric Anaesthetists Association Partnerships for Children, Families, Women and Maternity Pelvic Partnership PERIGON (formerly the NHS Modernisation Agency) Phoenix Partnership PNI ORG UK Positively Women Post Natal Illness Organisation (PNI) Primary Care Pharmacists' Association PRIMIS+ Princess Alexandra Hospital NHS Trust Queen Mary's Hospital NHS Trust (Sidcup) Regional Maternity Survey Office Regional Public Health Group – London Royal College of General Practitioners Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Psychiatrists Royal College of Radiologists Royal Liverpool Children's Trust Royal Society of Medicine Salford Royal Hospitals NHS Foundation Trust Salisbury NHS Foundation Trust Sandwell and West Birmingham NHS Trust Sanofi Pasteur MSD Scottish Executive Health Department Scottish Intercollegiate Guidelines Network (SIGN) Sefton PCT Sheffield South West PCT Sheffield Teaching Hospitals NHS Trust Sickle Cell & Thalassaemia Association of Counsellors Sickle Cell Society Society and College of Radiographers Survivors Trust TIPS Limited
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Guideline Development Group membership and acknowledgements
UK Coalition of People Living with HIV & AIDS UK Forum on Haemoglobin Disorders UK National Screening Committee UK Newborn Screening Programme Centre UK Thalassaemia Society UNICEF Baby Friendly Initiative United Lincolnshire Hospitals NHS Trust University College London Hospitals NHS Foundation Trust University College London Hospitals NHS Trust University Hospitals of Leicester Victim Support Welsh Assembly Government Welsh Scientific Advisory Committee (WSAC) West Middlesex University Hospital NHS Trust Western Cheshire PCT Wiltshire PCT Wirral University Hospital Teaching NHS Trust Women's Health Research Group Worcestershire Acute NHS Trust Worthing and Southlands Hospital NHS Trust Worthing Hospital Wyre Forest PCT York NHS Trust Yorkshire and Humber Local Supervisory Authority
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Abbreviations
AC ACHOIS ACOG ACTH ADA AFG AFI AFP AIDS ALPHA ANC APEC APH ASB BD BERR BMC BMI BP BPD BV BW CAMP cBG120 min CDSC CEGEN cFBG CFGC cfu/ml CHO CI CINAHL CMV CNS COMA CPC CRL CRP CS CTG DA DARE df DFA DNA DR DS Dx eAg EB xii abdominal circumference Australian Carbohydrate Intolerance Study in Pregnant Women American College of Obstetricians and Gynecologists adrenocorticotrophic hormone American Diabetes Association adequate fetal growth amniotic fluid index alpha-fetoprotein acquired immune deficiency syndrome Antenatal Psychosocial Health Assessment antenatal care Action on Pre-eclampsia antepartum haemorrhage asymptomatic bacteriuria twice a day Department for Business, Enterprise and Regulatory Reform bone mineral content body mass index blood pressure biparietal diameter or bronchopulmonary dysplasia bacterial vaginosis birthweight Christie, Atkinson, Munch, Peterson test capillary blood glucose 120 minutes after glucose load Communicable Disease Surveillance Centre Confidential Enquiry into Counselling for Genetic Disorders capillary fasting blood glucose customised fetal growth chart colony-forming units per millilitre carbohydrate confidence interval Cumulative Index to Nursing and Allied Health Literature cytomegalovirus central nervous system Committee on Medical Aspects of Food Policy choroid plexus cyst crown–rump length C-reactive protein caesarean section cardiotocography direct agglutination test Database of Abstracts and Reviews of Effectiveness degrees of freedom direct fluorescent antibody test deoxyribonucleic acid detection rate Down's syndrome Diagnosis hepatitis e antigen elementary body
2008 update
Abbreviations
ECV EEA EFW EIA EL ELISA EOGBS EPDS EPIC EU FBC FFN FGM FGR fl FL FPG FPR FTA-abs GA GBS GCT GD GDG GDM GPP GTT H/O HADS Hb HBIG HBsAg HBV HC hCG β-hCG HCV HDN HEED HELLP HIV HPA HPLC HSI HT HTA ICD-9 ICER IFG IGT IL IM IMDA IPC IPV IU IUGR LA
external cephalic version European Economic Area estimated fetal weight enzyme immunoassay evidence level enzyme-linked immunosorbent assay early-onset group B streptococcus Edinburgh Postnatal Depression Scale external intermittent pneumatic compression European Union full blood count fetal fibronectin female genital mutilation fetal growth restriction femtolitre (1015 litres) femur length fasting plasma glucose false positive rate fluorescent treponemal antibody – absorbed test gestational age group B streptococcus glucose challenge test gestational diabetes Guideline Development Group gestational diabetes mellitus good practice point glucose tolerance test history of Hospital Anxiety and Depression Scale haemoglobin hepatitis B immune globulin hepatitis B surface antigen hepatitis B virus head circumference human chorionic gonadotrophin (can be total or free beta) beta-human chorionic gonadotrophin hepatitis C virus haemolytic disease of the newborn Health Economic Evaluations Database haemolysis, elevated liver enzymes and low platelet count human immunodeficiency virus Health Protection Agency high-performance liquid chromatography health sector initiative hypertension Health Technology Assessment International Classification of Diseases, 9th edition incremental cost-effectiveness ratio inadequate fetal growth impaired glucose tolerance interleukin intramuscular(ly) interactive multimedia decision aid intrapartum care intimate partner violence international unit intrauterine growth restriction latex agglutination test
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LBW LCR LE LGA LMP LR LR LR+ LSHTM MCH MCV MeSH MIDIRS MMIC MoM MOMP MSAFP MSHCG MSS MSU MTCT NCC-WCH NCRSP NEC NFG NHS EED NHS NICE NICU NNT NPI NPV NS NSC NSF NT NTD OGTT OH 25-OHD ONS OR OTC oz PAI PAPP-A PCR PCT PE pg PHLS PI PIH PPV PROM PTD QID RBC
low birthweight ligase chain reaction leucocyte esterase large for gestational age last menstrual period likelihood ratio negative likelihood ratio positive likelihood ratio London School of Hygiene & Tropical Medicine mean corpuscular haemoglobin mean corpuscular volume medical subject headings Midwives Information and Resource Service Multidimensional Measure of Informed Choice multiples of the median major outer membrane protein maternal serum alpha-fetoprotein maternal serum beta-human chorionic gonadotrophin maternal serum screening midstream urine sample mother-to-child transmission National Collaborating Centre for Women's and Children's Health National Congenital Rubella Surveillance Programme necrotising enterocolitis normal fetal growth NHS Economic Evaluations Database National Health Service National Institute for Health and Clinical Excellence neonatal intensive care unit number needed to treat Neonatal Perception Inventory negative predictive value not significant (UK) National Screening Committee National Service Framework nuchal translucency neural tube defect oral glucose tolerance test oligohydramnios 25-hydroxyvitamin D Office for National Statistics odds ratio over-the-counter fluid ounce (28.41 ml) Prenatal Attachment Inventory pregnancy-associated plasma protein-A polymerase chain reaction primary care trust pre-eclampsia picogram (1012 grams) Public Health Laboratory Service pulsatility index pregnancy-induced hypertension positive predictive value preterm rupture of the membranes preterm delivery four times a day red blood cell
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Abbreviations
RBG RCOG RCT RhD RIBA RNA ROC ROP RPG RPR RR RST S/D SACN SD SE SFH SGA SIGN SP SPD SPTB ST STAI T 21/18/13 TDS TGA TPHA TVS uE3 UHT UK US CDC US USPSTF USS UTI VDRL VE WHO WMD
random blood glucose Royal College of Obstetricians and Gynaecologists randomised controlled trial rhesus D recombinant immunoblot assay ribonucleic acid receiver operating characteristic retinopathy of prematurity random plasma glucose rapid plasmin reagin test relative risk reagent strip testing systolic/diastolic Scientific Advisory Committee on Nutrition standard deviation socio-economic(ally) symphysis–fundal height small for gestational age Scottish Intercollegiate Guidelines Network specificity symphysis pubis dysfunction spontaneous preterm birth sensitivity Spielberger State-Trait Anxiety Inventory trisomy 21, 18 or 13 three times a day tranposition of the great arteries Treponema pallidum haemagglutination assay transvaginal sonography unconjugated estriol ultra-high-temperature processing United Kingdom United States Centers for Disease Control and Prevention ultrasound US Preventive Services Task Force ultrasound scan urinary tract infection Venereal Disease Research Laboratory (test for syphilis) vaginal examination World Health Organization weighted mean difference
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Glossary of terms
Bias Influences on a study that can lead to invalid conclusions about a treatment or intervention. Bias in research can make a treatment look better or worse than it really is. Bias can even make it look as if the treatment works when it actually doesn't. Bias can occur by chance or as a result of systematic errors in the design and execution of a study. Bias can occur at different stages in the research process, e.g. in the collection, analysis, interpretation, publication or review of research data. The practice of keeping the investigators or subjects of a study ignorant of the group to which a subject has been assigned. For example, a clinical trial in which the participating patients or their doctors are unaware of whether they (the patients) are taking the experimental drug or a placebo (dummy treatment). The purpose of 'blinding' or 'masking' is to protect against bias. See also double-blind study. A person's weight (in kilograms) divided by the square of their height (in metres). It is used as a measure of underweight, overweight or obesity. The appointment where the woman enters the maternity care pathway, characterised by information giving and detailed history-taking to help the woman choose the most appropriate antenatal care pathway. Also includes measurement of height, weight, blood pressure and blood tests for determining blood group, rubella status and haemoglobin level. Blood and urine samples for screening may also be taken at booking after the woman has been well informed and has given her consent. The booking appointment follows the first contact with a health professional. A study that starts with the identification of a group of individuals sharing the same characteristics (e.g. people with a particular disease) and a suitable comparison (control) group (e.g. people without the disease). All subjects are then assessed with respect to things that happened to them in the past, e.g. things that might be related to getting the disease under investigation. Such studies are also called retrospective as they look back in time from the outcome to the possible causes.
Blinding or masking
Body mass index (BMI) Booking
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Case–control study
Case report (or case study) Detailed report on one patient (or case), usually covering the course of that person's disease and their response to treatment. Case series Clinical effectiveness Description of several cases of a given disease, usually covering the course of the disease and the response to treatment. There is no comparison (control) group of patients. The extent to which a specific treatment or intervention, when used under usual conditions, has a beneficial effect on the course or outcome of a disease compared with no treatment or routine care. The term is sometimes used in guideline development to refer to the questions about treatment and care that are formulated in order to guide the search for research evidence. A research study conducted with patients which tests out a drug or other intervention to assess its effectiveness and safety. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease. This general term encompasses controlled clinical trials and randomised controlled trials. A group of patients, rather than an individual, used as a basic unit for investigation. See also cluster randomisation. A study in which groups of individuals (eg. attending one GP surgery) are randomly allocated to intervention groups. See also cluster. A group of people sharing some common characteristic (e.g. patients with the same disease), followed up in a research study for a specified period of time.
Clinical question Clinical trial
Cluster Cluster randomisation Cohort
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Cohort study
An observational study that takes a group (cohort) of patients and follows their progress over time in order to measure outcomes such as disease or mortality rates and make comparisons according to the treatments or interventions that patients received. Thus within the study group, subgroups of patients are identified (from information collected about patients) and these groups are compared with respect to outcome, e.g. comparing mortality between one group that received a specific treatment and one group which did not (or between two groups that received different levels of treatment). Cohorts can be assembled in the present and followed into the future (a concurrent or prospective cohort study) or identified from past records and followed forward from that time up to the present (a historical or retrospective cohort study). Because patients are not randomly allocated to subgroups, these subgroups may be quite different in their characteristics and some adjustment must be made when analysing the results to ensure that the comparison between groups is as fair as possible. A battery of screening tests used together to determine the risk of the unborn baby having Down's Syndrome. The tests are: a nuchal translucency ultrasound scan plus blood tests to measure levels of a beta human chorionic gonadotrophin and pregnancy-associated plasma protein-A. The test should be performed between 11 weeks 0 days and 13 weeks 6 days. A way of expressing certainty about the findings from a study or group of studies, using statistical techniques. A confidence interval describes a range of possible effects (of a treatment or intervention) that is consistent with the results of a study or group of studies. A wide confidence interval indicates a lack of certainty or precision about the true size of the clinical effect and is seen in studies with too few patients. Where confidence intervals are narrow they indicate more precise estimates of effects and a larger sample of patients studied. It is usual to interpret a '95%' confidence interval as the range of effects within which we are 95% confident that the true effect lies.
Combined test
Confidence interval
Confounder or confounding Something that influences a study and can contribute to misleading findings if it is not variable/factor understood and appropriately dealt with. Consensus methods
Consistency Control group
The extent to which the conclusions of a collection of studies used to support a guideline recommendation are in agreement with each other. See also homogeneity. A group of patients recruited into a study that receives no treatment, a treatment of known effect, or a placebo (dummy treatment), in order to provide a comparison for a group receiving an experimental treatment, such as a new drug. A study testing a specific drug or other treatment involving two (or more) groups of patients with the same disease. One (the experimental group) receives the treatment that is being tested, and the other (the comparison or control group) receives an alternative treatment, a placebo (dummy treatment) or no treatment. The two groups are followed up to compare differences in outcomes to see how effective the experimental treatment was. A CCT where patients are randomly allocated to treatment and comparison groups is called a randomised controlled trial. A type of economic evaluation where both costs and benefits of healthcare treatment are measured in the same monetary units. If benefits exceed costs, the evaluation would recommend providing the treatment. A type of economic evaluation that assesses the additional costs and benefits of doing something different. In cost-effectiveness analysis, the costs and benefits of different treatments are compared. When a new treatment is compared with current care, its additional costs divided by its additional benefits is called the cost-effectiveness ratio. Benefits are measured in natural units, for example, cost per additional heart attack prevented. A special form of cost-effectiveness analysis where benefit is measured in quality-adjusted life years (QALYs). A treatment is assessed in terms of its ability to extend or improve the quality of life. For the purpose of the guideline, 'counselling' is defined broadly as supportive listening, advice giving and information. The British Association for Counselling and Psychotherapy offers a more specific definition of counselling as a discrete psychological intervention (regular planned meetings of usually 50 minutes in length) which is facilitative, nondirective and/or relationship focused, with the content of sessions largely determined by the service user'.
Controlled clinical trial (CCT)
Cost–benefit analysis
Cost-effectiveness
Cost–utility analysis
Counselling
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A variety of techniques that aim to reach an agreement on a particular issue. Formal consensus methods include Delphi or nominal group techniques, and consensus development conferences. In the development of a clinical guideline, consensus methods may be used where there is a lack of good research evidence.
Antenatal care
Crossover study design
A study comparing two or more interventions in which the participants, upon completion of the course of one treatment, are switched to another. For example, for a comparison of treatments A and B, half the participants are randomly allocated to receive them in the order A, B and half to receive them in the order B, A. A problem with this study design is that the effects of the first treatment may carry over into the period when the second is given. Therefore a crossover study should include an adequate 'wash-out' period, which means allowing sufficient time between stopping one treatment and starting another so that the first treatment has time to wash out of the patient's system. The observation of a defined set of people at a single point in time or time period – a snapshot. (This type of study contrasts with a longitudinal study, which follows a set of people over a period of time.) The customised fetal growth chart (CFGC) is the term used for an individually adjusted standard for fundal height, estimated fetal weight and birthweight which takes into consideration maternal characteristics such as height, country of family origin, cigarette smoking and presence of diabetes. A technique used for the purpose of reaching an agreement on a particular issue, without the participants meeting or interacting directly. It involves sending participants a series of postal questionnaires asking them to record their views. After the first questionnaire, participants are asked to give further views in the light of the group feedback. The judgements of the participants are statistically aggregated. See also consensus methods. 100% minus sensitivity. Confirmation of the presence of a disease/disorder. A study to assess the effectiveness of a test or measurement in terms of its ability to accurately detect or exclude a specific disease. A study in which neither the subject (patient) nor the observer (investigator or clinician) is aware of which treatment or intervention the subject is receiving. The purpose of blinding is to protect against bias. The process of systematically finding, appraising and using research findings as the basis for clinical decisions. Evidence-based clinical practice involves making decisions about the care of individual patients based on the best research evidence available rather than basing decisions on personal opinions or common practice (which may not always be evidence based). Evidence-based clinical practice therefore involves integrating individual clinical expertise and patient preferences with the best available evidence from research. A code (eg. 1++, 1+) linked to an individual study or systematic review indicating where it fits in the hierarchy of evidence and how well it has adhered to recognised research principles. A table summarising the results of a collection of studies which, taken together, represent the evidence supporting a particular recommendation or series of recommendations in a guideline. See Selection criteria. A research study designed to test whether a treatment or intervention has an effect on the course or outcome of a condition or disease, where the conditions of testing are to some extent under the control of the investigator. Controlled clinical trials and randomised controlled trials are examples of experimental studies. 100% minus specificity. The initial appointment where the woman first meets a healthcare professional with a confirmed pregnancy. This appointment includes referral into the maternity care pathway and is an opportunity for information giving to ensure the woman is able to make informed decisions about her pregnancy care, including all antenatal screening and to raise awareness about health-related issues that are particularly relevant in early pregnancy. A method, procedure or measurement that is widely accepted as being the best available. Pregnant. A systematically developed tool that describes aspects of a person's condition and the care to be given. A good guideline makes recommendations based on best research evidence available, rather than opinion. It is used to assist clinician and patient decision making about appropriate health care for specific conditions.
Cross-sectional study
Customised fetal growth chart
Delphi technique
Detection rate Diagnosis Diagnostic study Double-blind study
2008 update
Evidence based Evidence-based clinical practice
Evidence level (EL) Evidence table
Exclusion criteria Experimental study
False positive rate First contact
Gold standard Gravid Guideline
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Glossary of terms
Health economics Health technology Heterogeneity
A field of conventional economics which examines the benefits of healthcare interventions (e.g. medicines) compared with their financial costs. Health technologies include medicines, medical devices, diagnostic techniques, surgical procedures, health promotion activities and other therapeutic interventions. Or lack of homogeneity. The term is used in meta-analyses and systematic reviews when the results or estimates of effects of treatment from separate studies seem to be very different, in terms of the size of treatment effects, or even to the extent that some indicate beneficial and others suggest adverse treatment effects. Such results may occur as a result of differences between studies in terms of the patient populations, outcome measures, definition of variables or duration of follow up. An established hierarchy of study types, based on the degree of certainty that can be attributed to the conclusions that can be drawn from a well-conducted study. Wellconducted randomised controlled trials (RCTs) are at the top of this hierarchy. This means that the results of studies included in a systematic review or meta-analysis are similar and there is no evidence of heterogeneity. Results are usually regarded as homogeneous when differences between studies could reasonably be expected to occur by chance. See also consistency. See selection criteria. A battery of screening tests used together to determine the risk of the unborn baby having Down's syndrome. The tests are: a nuchal translucency ultrasound scan plus blood tests to measure levels of a beta human chorionic gonadotrophin (β-hCG)and pregnancy-associated plasma protein-A. These tests should be performed between 11 weeks 0 days and 13 weeks 6 days. This is then followed by a second battery of blood tests: alpha-fetoprotein, uE3 and inhibin A between 15 weeks 0 days and 20 weeks 0 days. The woman waits for results from the second set of tests before she is told her risk level. An analysis of a clinical trial where particpants are analysed according to the group to which they are initially randomly allocated, regardless of whether or not they had dropped out of the study, fully received the intervention as intended or crossed over to an alternative intervention. Healthcare action intended to benefit the patient, e.g. drug treatment, surgical procedure, psychological therapy. See negative likelihood ratio and positive likelihood ratio. A study of the same group of people at more than one point in time. (This type of study contrasts with a cross-sectional study, which observes a defined set of people at a single point in time.) See blinding. Results from a collection of independent studies (investigating the same treatment) are pooled, using statistical techniques to synthesise their findings into a single estimate of a treatment effect. Where studies are not compatible, e.g. because of differences in the study populations or in the outcomes measured, it may be inappropriate or even misleading to statistically pool results in this way. See also systematic review and heterogeneity. Having carried more than one pregnancy to a viable stage. The negative likelihood ratio describes the probability of having a negative test result in the diseased population compared with that of a non-diseased population and corresponds to the ratio of the false negative rate divided by the true negative rate ((1 – sensitivity)/specificity). The proportion of people with a negative test result who do not have the disease (where not having the disease is indicated by the gold test being negative). A technique used for the purpose of reaching an agreement on a particular issue. It uses a variety of postal and direct contact techniques, with individual judgements being aggregated statistically to derive the group judgement. See also consensus methods. A study based on subjects selected on the basis of their availability, with no attempt having been made to avoid problems of bias. Having never given birth to a viable infant.
Hierarchy of evidence
Homogeneity
Inclusion criteria Integrated test
Intention-to-treat analysis
Intervention Likelihood ratio Longitudinal study
Masking Meta-analysis
Multiparous Negative likelihood ratio (LR–) Negative predictive value (NPV) Nominal group technique
Non-experimental study Nulliparous
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Number needed to treat (NNT)
This measures the impact of a treatment or intervention. It states how many patients need to be treated with the treatment in question in order to prevent an event that would otherwise occur; e.g. if the NNT = 4, then four patients would have to be treated to prevent one bad outcome. The closer the NNT is to one, the better the treatment is. Analogous to the NNT is the number needed to harm (NNH), which is the number of patients that would need to receive a treatment to cause one additional adverse event. e.g. if the NNH = 4, then four patients would have to be treated for one bad outcome to occur. In research about diseases or treatments, this refers to a study in which nature is allowed to take its course. Changes or differences in one characteristic (e.g. whether or not people received a specific treatment or intervention) are studied in relation to changes or differences in other(s) (e.g. whether or not they died), without the intervention of the investigator. There is a greater risk of selection bias than in experimental studies. Odds are a way of representing probability, especially familiar from betting. In recent years odds ratios have become widely used in reports of clinical studies. They provide an estimate (usually with a confidence interval) for the effect of a treatment. Odds are used to convey the idea of 'risk' and an odds ratio of one between two treatment groups would imply that the risks of an adverse outcome were the same in each group. For rare events the odds ratio and the relative risk (which uses actual risks and not odds) will be very similar. See also relative risk, risk ratio. Having borne at least one viable offspring (usually more than 24 weeks of gestation). Review of a study, service or recommendations by those with similar interests and expertise to the people who produced the study findings or recommendations. Peer reviewers can include professional, patient and carer representatives. A small-scale 'test' of the research instrument. For example, testing out (piloting) a new questionnaire with people who are similar to the population of the study, in order to highlight any problems or areas of concern, which can then be addressed before the fullscale study begins. Placebos are fake or inactive treatments received by participants allocated to the control group in a clinical trial, which are indistinguishable from the active treatments being given in the experimental group. They are used so that participants are ignorant of their treatment allocation in order to be able to quantify the effect of the experimental treatment over and above any placebo effect due to receiving care or attention. A beneficial (or adverse) effect produced by a placebo and not due to any property of the placebo itself. The positive likelihood ratio describes the probability of having a positive test result in the diseased population compared with that of a non-diseased population and corresponds to the ratio of the true positive rate divided by the false positive rate (sensitivity/(1specificity)). The proportion of people with a positive test result who have the condition (where having the condition is indicated by the gold standard test being positive). See statistical power. A study in which people are entered into the research and then followed up over a period of time with future events recorded as they happen. This contrasts with studies that are retrospective. If a study is done to compare two treatments then the P value is the probability of obtaining the results of that study, or something more extreme, if there really was no difference between treatments. (The assumption that there really is no difference between treatments is called the 'null hypothesis'.) Suppose the P value was 0.03. What this means is that, if there really was no difference between treatments, there would only be a 3% chance of getting the kind of results obtained. Since this chance seems quite low we should question the validity of the assumption that there really is no difference between treatments. We would conclude that there probably is a difference between treatments. By convention, where the value of P is below 0.05 (i.e. less than 5%) the result is seen as statistically significant. Where the value of P is 0.001 or less, the result is seen as highly significant. P values just tell us whether an effect can be regarded as statistically significant or not. In no way do they relate to how big the effect might be, for which we need the confidence interval.
Observational study
Odds ratio (OR)
Parous Peer review
Pilot study
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Placebo
Placebo effect Positive likelihood ratio (LR+) Positive predictive value (PPV) Power Prospective study
P value
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Qualitative research
Qualitative research is used to explore and understand people's beliefs, experiences, attitudes, behaviour and interactions. It generates non-numerical data, e.g. a patient's description of their pain rather than a measure of pain. In health care, qualitative techniques have been commonly used in research documenting the experience of chronic illness and in studies about the functioning of organisations. Qualitative research techniques such as focus groups and in-depth interviews have been used in one-off projects commissioned by guideline development groups to find out more about the views and experiences of patients and carers. A measure of health outcome that looks at both length of life and quality of life. QALYs are calculated by estimating the years of life remaining for a person following a particular care pathway and weighting each year with a quality of life score (on a zero to one scale). One QALY is equal to 1 year of life in perfect health, or 2 years at 50% health, and so on. Research that generates numerical data or data that can be converted into numbers, for example clinical trials or the National Census, which counts people and households. A method that uses the play of chance to assign participants to comparison groups in a research study; for example, by using a random numbers table or a computer-generated random sequence. Random allocation implies that each individual (or each unit in the case of cluster randomisation) being entered into a study has the same chance of receiving each of the possible interventions. A study to test a specific drug or other treatment in which people are randomly assigned to two (or more) groups: one (the experimental group) receiving the treatment that is being tested, and the other (the comparison or control group) receiving an alternative treatment, a placebo (dummy treatment) or no treatment. The two groups are followed up to compare differences in outcomes to see how effective the experimental treatment was. (Through randomisation, the groups should be similar in all aspects apart from the treatment they receive during the study.) A summary measure which represents the ratio of the risk of a given event or outcome (e.g. an adverse reaction to the drug being tested) in one group of subjects compared with another group. When the 'risk' of the event is the same in the two groups the relative risk is 1. In a study comparing two treatments, a relative risk of 2 would indicate that patients receiving one of the treatments had twice the risk of an undesirable outcome than those receiving the other treatment. Relative risk is sometimes used as a synonym for risk ratio. Reliability refers to a method of measurement that consistently gives the same results. For example, someone who has a high score on one occasion tends to have a high score if measured on another occasion very soon afterwards. With physical assessments it is possible for different clinicians to make independent assessments in quick succession and if their assessments tend to agree then the method of assessment is said to be reliable. A retrospective study deals with the present and past and does not involve studying future events. This contrasts with studies that are prospective. Ratio of the risk of an undesirable event or outcome occurring in a group of patients receiving experimental treatment compared with a comparison (control) group. The term relative risk is sometimes used as a synonym of risk ratio. A part of the study's target population from which the subjects of the study will be recruited. If subjects are drawn in an unbiased way from a particular population, the results can be generalised from the sample to the population as a whole. Screening is a public health service in which members of a defined population, who do not necessarily perceive they are at risk of, or are already affected by a disease or its complications, are asked a question or offered a test, to identify those individuals who are more likely to be helped than harmed by further tests or treatment to reduce the risk of a disease or its complications. Explicit standards used by guideline development groups to decide which studies should be included and excluded from consideration as potential sources of evidence. In diagnostic testing, sensitivity refers to the proportion of cases with the target condition correctly identified by the diagnostic test out of all the cases that have the target condition. In diagnostic testing, specificity refers to the proportion of cases without the target condition correctly identified by the diagnostic test out of all the cases that do not have the target condition.
Quality-adjusted life years (QALYs)
Quantitative research Random allocation or randomisation
Randomised controlled trial
Relative risk (RR)
Reliability
Retrospective study Risk ratio
Sample
Screening
Selection criteria Sensitivity Specificity
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Statistical power
The ability of a study to demonstrate an association or causal relationship between two variables, given that an association exists. For example, 80% power in a clinical trial means that the study has a 80% chance of ending up with a P value of less than 5% in a statistical test (i.e. a statistically significant treatment effect) if there really was an important difference (e.g. 10% versus 5% mortality) between treatments. If the statistical power of a study is low, the study results will be questionable (the study might have been too small to detect any differences). By convention, 80% is an acceptable level of power. See also P value. The kind of design used for a study. Randomised controlled trials, case–control studies and cohort studies are all examples of study types. A review in which evidence from scientific studies has been identified, appraised and synthesised in a methodical way according to predetermined criteria. May or may not include a meta-analysis. A technology appraisal, as undertaken by NICE, is the process of determining the clinical and cost-effectiveness of a health technology. NICE technology appraisals are designed to provide patients, health professionals and managers with an authoritative source of advice on new and exisiting health technologies. A procedure conducted to look for a pre-defined target of interest – either in terms of its presence/absence, or the amount/level contained in the body or a body fluid. Assessment of how well a tool or instrument measures what it is intended to measure. A measurement that can vary within a study, e.g. the age of participants. Variability is present when differences can be seen between different people or within the same person over time, with respect to any characteristic or feature that can be assessed or measured.
Study type Systematic review
Technology appraisal
Test Validity Variable
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1
1.0
Introduction
Introduction
The original antenatal care guideline was published by NICE in 2003. Since then a number of important pieces of evidence have become available, particularly concerning gestational diabetes, haemoglobinopathy and ultrasound, so that the update was initiated. This update has also provided an opportunity to look at a number of aspects of antenatal care: the development of a method to assess women for whom additional care is necessary (the 'antenatal assessment tool') information giving to women lifestyle: – vitamin D supplementation – alcohol consumption screening for the baby: – use of ultrasound for gestational age assessment and screening for fetal abnormalities – methods for determining normal fetal growth – placenta praevia screening for the mother: – haemoglobinopathy screening – gestational diabetes – pre-eclampsia and preterm labour – chlamydia.
1.1
Aim of the guideline
The ethos of this guideline is that pregnancy is a normal physiological process and that, as such, any interventions offered should have known benefits and be acceptable to pregnant women. The guideline has been developed with the following aims: to offer information on best practice for baseline clinical care of all pregnancies and comprehensive information on the antenatal care of the healthy woman with an uncomplicated singleton pregnancy. It provides evidence-based information for clinicians and pregnant women to make decisions about appropriate treatment in specific circumstances. The guideline will complement the Children's National Service Frameworks (England and Wales) (2004) which provides standards for service configuration, with emphasis on how care is delivered and by whom, including issues of ensuring equity of access to care for disadvantaged women and women's views about service provision (For more information, see www.dh.gov.uk/en/Healthcare/NationalServiceFrameworks/ChildrenServices/ index.htm for England and www.wales.nhs.uk/ sites3/page.cfm orgid=334&pid=934 for Wales). The guideline has also drawn on the evidence-based recommendations of the UK National Screening Committee (NSC). The Changing Childbirth report1 (1993) and Maternity Matters635 (2007) explicitly confirmed that women should be the focus of maternity care with an emphasis on providing choice, easy access and continuity of care. Care during pregnancy should enable a woman to make informed decisions, based on her needs, having discussed matters fully with the professionals involved. Reviews of women's views on antenatal care, including a comprehensive national survey conducted by the National Perinatal Epidemiology Unit,994 suggest that key aspects of care valued by women are respect, competence, communication, support and convenience.2 Access to information and provision of care by the same small group of people are also key aspects of care that lend themselves to a pregnant woman feeling valued as an individual and more in control.3 Current models of antenatal care originated in the early decades of the 20th century. The pattern of visits recommended at that time (monthly until 30 weeks, then fortnightly to 36 weeks and then 1
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weekly until delivery) is still recognisable today. It has been said that antenatal care has escaped critical assessment.4 Both the individual components and composite package of antenatal care should conform to the criteria for a successful screening programme, namely that: the condition being screened for is an important health problem the screening test (further diagnostic test and treatment) is safe and acceptable the natural history of the condition is understood early detection and treatment has benefit over later detection and treatment the screening test is valid and reliable treatments or interventions should be effective there are adequate facilities for confirming the test results and resources for treatment the objectives of screening justify the costs.
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A complete list of the NSC criteria for screening can be found in the NSC online library (www. nsc.nhs.uk/library/lib_ind.htm) under the title, The UK National Screening Committee's criteria for appraising the viability, effectiveness and appropriateness of a screening programme.
1.2
Areas outside the remit of the guideline
The guideline will not produce standards for service configuration, which have been addressed by the Children's National Service Frameworks (England and Wales), nor will it address quality standard issues (such as laboratory standards), which are addressed by the National Screening Committee.5 Although the guideline addresses screening for many of the complications of pregnancy, it does not include information on the investigation and appropriate ongoing management of these complications if they arise in pregnancy (for example, the management of pre-eclampsia, fetal anomalies and multiple pregnancies). Any aspect of intrapartum and postpartum care has not been included in this guideline. This includes preparation for birth and parenthood, risk factor assessment for intrapartum care, breastfeeding and postnatal depression. These topics will be addressed in future National Institute for Clinical Excellence (NICE) guidelines on intrapartum and postpartum care. In addition, preconception care is not covered in this guideline. The guideline offers recommendations on baseline clinical care for all pregnant women but it does not offer information on the additional care that some women will require. Pregnant women with the following conditions usually require care additional to that detailed in this guideline: cardiac disease, including hypertension renal disease hepatic disease endocrine disorders or diabetes psychiatric disorders (on medication) haematological disorders, including sickle cell or thalassaemia, thromboembolic disease, autoimmune diseases such as antiphospholipid syndrome epilepsy requiring anticonvulsant drugs malignant disease severe asthma drug use such as heroin, cocaine (including crack cocaine) and ecstasy HIV or hepatitis B virus (HBV) infected cystic fibrosis autoimmune disorders obesity (body mass index, BMI, 35 kg/m or more at first contact) or underweight (BMI less than 18 kg/m at first contact) women who may be at higher risk of developing complications e.g. women 40 years and older and women who smoke women who are particularly vulnerable (e.g. women 18 years or younger) or who lack social support family history of genetic disorder multiple pregnancy
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Introduction
women who have experienced any of the following in previous pregnancies: – recurrent miscarriage (three or more consecutive pregnancy losses) or a mid-trimester loss – severe pre-eclampsia, HELLP syndrome or eclampsia – rhesus isoimmunisation or other significant blood group antibodies – uterine surgery including caesarean section, myomectomy or cone biopsy – antenatal or postpartum haemorrhage on two occasions – retained placenta on two occasions – puerperal psychosis – grand multiparity (more than six pregnancies) – a stillbirth or neonatal death – a small-for-gestational-age (SGA) infant (less than fifth centile) – a large-for-gestational-age (LGA) infant (greater than 95th centile) – a baby weighing less than 2500 g or more than 4500 g – a baby with a congenital anomaly (structural or chromosomal).
1.3
For whom is the guideline intended
This guideline is of relevance to those who work in or use the National Health Service (NHS) in England and Wales: professional groups who share in caring for pregnant women, such as obstetricians, midwives, radiographers, physiotherapists, anaesthetists, general practitioners, paediatricians, pharmacists and others those with responsibilities for commissioning and planning maternity services, such as primary care trusts in England, Health Commission Wales, public health and trust managers pregnant women. A version of this guideline for pregnant women, their partners and the public is available from the NICE website (www.nice.org.uk/CG062publicinfo) or from NICE publications on 0845 003 7783 (quote reference number N1483).
1.4
Who has developed the guideline
The Guideline was developed by a multi-professional and lay working group, the Guideline Development Group (GDG), convened by the National Collaborating Centre for Women's and Children's Health (NCC-WCH). Membership included: two service user representatives two general practitioners two midwives two obstetricians a radiographer a neonatologist a representative from the Confidential Enquiry into Maternal Deaths (CEMD).
Staff from NCC-WCH provided methodological support for the guideline development process, undertook the systematic searches, retrieval and appraisal of the evidence and wrote successive drafts of the document. In accordance with the NICE guideline development process,6 all GDG members have made and updated any declarations of interest.
The guideline update was developed by a multi-professional and lay working group, the Guideline Development Group (GDG), convened by the National Collaborating Centre for Women's and Children's Health (NCC-WCH). Membership included: two service user representatives two midwives 3
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1.5
Who has developed the guideline update
2008
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two obstetricians a general practitioner an ultrasonographer an MRC-funded public health research fellow.
Staff from NCC-WCH provided methodological support for the guideline development process, undertook the systematic searches, retrieval and appraisal of the evidence and wrote successive drafts of the document. In accordance with the NICE guideline development process,6 all GDG members have made and updated any declarations of interest (Appendix A).
1.6
Guideline methodology
The development of the guideline was commissioned by the National Institute for Health and Clinical Excellence (NICE) and developed in accordance with the guideline development process outlined in The Guideline Development Process – Information for National Collaborating Centres and Guideline Development Groups, available from the NICE website (www.nice.org.uk).6
Update methodology
The guideline update was developed in accordance with the NICE guideline development process outlined in the 2006 and 2007 editions of the guidelines manual.632,633 Table 1.1 summarises the key stages of the guideline development process and which version of the process was followed at each stage. Table 1.1 Stages in the NICE guideline development process and the versions followed at each stage
Stage Scoping the guideline (determining what the guideline would and would not cover) Preparing the work plan (agreeing timelines, milestones, Guideline Development Group constitution, etc.) Forming and running the Guideline Development Group Developing clinical questions Identifying the evidence Reviewing and grading the evidence Incorporating health economics Making group decisions and reaching consensus Linking guidance to other NICE guidance Creating guideline recommendations Developing clinical audit criteria Writing the guideline Validation (stakeholder consultation on the draft guideline) Declaration of interestsa
a
2006 version 2007 version
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The process for declaring interests was extended in November 2006 to cover NCC-WCH staff and to include personal family interests.
Literature search strategy
The aim of the literature review was to identify and synthesise relevant evidence within the published literature, in order to answer the specific clinical questions. Searches were performed using generic and specially developed filters, relevant MeSH (medical subject headings) terms and free-text terms. Details of all literature searches are available upon application to the NCC-WCH.
4
Introduction
Guidelines by other development groups were searched for on the National Guidelines Clearinghouse database, the TRIP database and OMNI service on the Internet. The reference lists in these guidelines were checked against the searches to identify any missing evidence. Searches were carried out for each topic of interest. The Cochrane Database of Systematic Reviews, up to Issue 3, 2003, was searched to identify systematic reviews of randomised controlled trials, with or without meta-analyses and randomised controlled trials. The electronic database, MEDLINE (Ovid version for the period January 1966 to April 2003), EMBASE (Ovid version from January 1980 to April 2003), MIDIRS (Midwives Information and Resource Service), CINAHL (Cumulative Index to Nursing and Allied Health Literature), the British Nursing Index (BNI) and PsychInfo were also searched. The Database of Abstracts and Reviews of Effectiveness (DARE) was searched. Reference lists of nonsystematic review articles and studies obtained from the initial search were reviewed and journals in the RCOG library were hand-searched to identify articles not yet indexed. There was no systematic attempt to search the 'grey literature' (conferences, abstracts, theses and unpublished trials). A preliminary scrutiny of titles and abstracts was undertaken and full papers were obtained if they appeared to address the GDG's question relevant to the topic. Following a critical review of the full version of the study, articles not relevant to the subject in question were excluded. Studies that did not report on relevant outcomes were also excluded. Submitted evidence from stakeholders was included where the evidence was relevant to the GDG clinical question and when it was either better or equivalent in quality to the research identified in the literature searches. The economic evaluation included a search of: NHS Economic Evaluations Database (NHS EED) Health Economic Evaluation Database (HEED) Cochrane Database of Systematic Reviews, Issue 3, 2003 MEDLINE January 1966 to April 2003 EMBASE 1980 to April 2003.
Relevant experts in the field were contacted for further information. The search strategies were designed to find any economic study related to specific antenatal screening programmes. Abstracts and database reviews of papers found were reviewed by the health economist and were discarded if they appeared not to contain any economic data or if the focus of the paper did not relate to the precise topic or question being considered (i.e. to screening strategy alternatives that were not relevant to this guideline). Relevant references in the bibliographies of reviewed papers were also identified and reviewed. These were assessed by the health economists against standard criteria.
Literature search strategy for the 2008 update
Relevant published evidence to inform the guideline development process and answer the clinical questions was identified by systematic search strategies. Additionally, stakeholder organisations were invited to submit evidence for consideration by the GDG provided it was relevant to the clinical questions and of equivalent or better quality than evidence identified by the search strategies. Systematic searches to answer the clinical questions formulated and agreed by the GDG were executed using the following databases via the 'Ovid' platform: Medline (1966 onwards), Embase (1980 onwards), Cumulative Index to Nursing and Allied Health Literature (1982 onwards) and PsycINFO (1967 onwards). The most recent search conducted for the three Cochrane databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects) was during Quarter 1, 2007. Searches to identify economic studies were undertaken using the above databases, and the NHS Economic Evaluations Database (NHS EED). Search strategies combined relevant controlled vocabulary and natural language in an effort to balance sensitivity and specificity. Unless advised by the GDG, searches were not date specific. Language restrictions were not applied to searches. Both generic and specially developed methodological search filters were used appropriately.
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There was no systematic attempt to search grey literature (conferences, abstracts, theses and unpublished trials). Hand searching of journals not indexed on the databases was not undertaken. Towards the end of the guideline development process searches were re-executed, thereby including evidence published and included in the databases up to 8 June 2007. Any evidence published after this date was not included. This date should be considered the starting point for searching for new evidence for future updates to this guideline. Further details of the search strategies, including the methodological filters employed, are available on an accompanying disc.
Clinical effectiveness
For all the subject areas, evidence from the study designs least subject to sources of bias was included. Where possible, the highest levels of evidence were used, but all papers were reviewed using established guides (see below). Published systematic reviews or meta-analyses were used if available. For subject areas where neither was available, other appropriate experimental or observational studies were sought. Identified articles were assessed methodologically and the best available evidence was used to form and support the recommendations. The highest level of evidence was selected for each clinical question. Using the evidence-level structure shown in Table 1.2, the retrieved evidence was graded accordingly. Table 1.2
Level 1a 1b 2a 2b 3 4
Structure of evidence levels
Definition Systematic review and meta-analysis of randomised controlled trials At least one randomised controlled trial At least one well-designed controlled study without randomisation At least one other type of well-designed quasi-experimental study Well-designed non-experimental descriptive studies, such as comparative studies, correlation studies or case studies Expert committee reports or opinions and/or clinical experience of respected authorities
Hierarchy of evidence
The clinical question dictates the highest level of evidence that should be sought. For issues of therapy or treatment, the highest level of evidence is meta-analyses of randomised controlled trials or randomised controlled trials themselves. This would equate to a grade A recommendation. For issues of prognosis, a cohort study is the best level of evidence available. The best possible level of evidence would equate to a grade B recommendation. It should not be interpreted as an inferior grade of recommendation, as it represents the highest level of evidence attainable for that type of clinical question. For diagnostic tests, test evaluation studies examining the performance of the test were used if the efficacy of the test was required. Where an evaluation of the effectiveness of the test on management and outcome was required, evidence from randomised controlled trials or cohort studies was sought. All retrieved articles have been appraised methodologically using established guides. Where appropriate, if a systematic review, meta-analysis or randomised controlled trial existed in relation to a topic, studies of a weaker design were not sought. The evidence was synthesised using qualitative methods. These involved summarising the content of identified papers in the form of evidence tables and agreeing brief statements that accurately reflect the relevant evidence. Quantitative techniques (meta-analyses) were performed if appropriate and necessary.
6
Introduction
For the purposes of this guideline, data are presented as relative risk (RR) where relevant (i.e. in RCTs and cohort studies) or as odds ratios (OR) where relevant (i.e. in systematic reviews of RCTs). Where these data are statistically significant they are also presented as numbers needed to treat (NNT), if relevant.
Appraisal and synthesis of clinical effectiveness evidence for the 2008 update
Evidence relating to clinical effectiveness was reviewed and classified using the established hierarchical system presented in Table 1.3.632,633 This system reflects the susceptibility to bias that is inherent in particular study designs. The type of clinical question dictates the highest level of evidence that may be sought. In assessing the quality of the evidence, each study was assigned a quality rating coded as '++', '+' or ''. For issues of therapy or treatment, the highest possible evidence level (EL) is a well-conducted systematic review or meta-analysis of randomised controlled trials (RCTs; EL = 1++) or an individual RCT (EL = 1+). Studies of poor quality were rated as ''. Usually, studies rated as '' should not be used as a basis for making a recommendation, but they can be used to inform recommendations. For issues of prognosis, the highest possible level of evidence is a cohort study (EL = 2). A level of evidence was assigned to each study appraised during the development of the guideline. For each clinical question, the highest available level of evidence was selected. Where appropriate, for example, if a systematic review, meta-analysis or RCT existed in relation to a question, studies of a weaker design were not considered. Where systematic reviews, meta-analyses and RCTs did not exist, other appropriate experimental or observational studies were sought. For diagnostic tests, test evaluation studies examining the performance of the test were used if the effectiveness (accuracy) of the test was required, but where an evaluation of the effectiveness of the test in the clinical management of patients and the outcome of disease was required, evidence from RCTs or cohort studies was optimal. For studies evaluating the accuracy of a diagnostic test, sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs) were calculated or quoted where possible (see Table 1.4).
Table 1.3
Level 1++ 1+ 1 2++
Levels of evidence for intervention studies
Source of evidence High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias High-quality systematic reviews of case–control or cohort studies; high-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal Non-analytical studies (for example, case reports, case series) Expert opinion, formal consensus
2+ 2 3 4
Table 1.4
Test positive
'2 × 2' table for calculation of diagnostic accuracy parameters
Reference standard positive a (true positive) c (false negative) a+c Reference standard negative Total b (false positive) d (true negative) b+d a+b c+d a+b+c+d = N (total number of tests in study)
Test negative Total
Sensitivity = a/(a+c), specificity = d/(b+d), PPV = a/(a+b), NPV = d/(c+d)
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The system described above covers studies of treatment effectiveness. However, it is less appropriate for studies reporting accuracy of diagnostic tests. In the absence of a validated ranking system for this type of test, NICE has developed a hierarchy of evidence that takes into account the various factors likely to affect the validity of these studies (see Table 1.5).633 Table 1.5
Level Ia Ib II III IV
a
Levels of evidence for studies of the accuracy of diagnostic tests
Type of evidence Systematic review (with homogeneity)a of level-1 studiesb Level-1 studiesb Level-2 studiesc; systematic reviews of level-2 studies Level-3 studiesd; systematic reviews of level-3 studies Consensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or 'first principles'
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b
c
Homogeneity means there are no or minor variations in the directions and degrees of results between individual studies that are included in the systematic review. Level-1 studies are studies that use a blind comparison of the test with a validated reference standard (gold standard) in a sample of patients that reflects the population to whom the test would apply. Level-2 studies are studies that have only one of the following: narrow population (the sample does not reflect the population to whom the test would apply) use a poor reference standard (defined as that where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference') the comparison between the test and reference standard is not blind case–control studies. Level-3 studies are studies that have at least two or three of the features listed above.
d
Health economics
In antenatal care, there is a relatively large body of economic literature that has considered the economic costs and consequences of different screening programmes and considered the organisation of antenatal care. The purpose of including economic evidence in a clinical guideline is to allow recommendations to be made not just on the clinical effectiveness of different forms of care, but on the cost-effectiveness as well. The aim is to produce guidance that uses scarce health service resources efficiently; that is, providing the best possible care within resource constraints. The economic evidence is focused around the different methods of screening, although some work has been undertaken to examine the cost-effectiveness of different patterns of antenatal care (the number of antenatal appointments) and to explore women's preferences for different aspects of their antenatal care. The economic evidence presented in this guideline is not a systematic review of all the economic evidence around antenatal care. It was decided that the health economic input into the guideline should focus on specific topics where the GDG thought that economic evidence would help them to inform their decisions. This approach was made on pragmatic grounds (not all the economic evidence could be reviewed with the resources available) and on the basis that economic evidence should not be based only on the economic literature, but should be consistent with the clinical effectiveness evidence presented in the guideline. Some of the economic evaluation studies did not address the specific alternatives (say, for screening) that were addressed in the guideline. Therefore, for each of the specific topic areas where the economic evidence was reviewed, a simple economic model was developed in order to present the GDG with a coherent picture of the costs and consequences of the decisions based on the clinical and economic evidence. The role of the health economist in this guideline was to review the literature in these specific areas and obtain cost data considered to be the closest to current UK opportunity cost (the value of the resources used, rather than the price or charge). The approach adopted for this guideline was for the health economic analysis to focus on specific areas. Topics for economic analysis were selected on the following basis by the GDG. Does the proposed topic have major resource implications Is there a change of policy involved
8
Introduction
Are there sufficient data of adequate quality to allow useful review or modelling Is there a lack of consensus among clinicians Is there a particular area with a large amount of uncertainty Where the above answers were 'yes', this indicated that further economic analysis including modelling is more likely to be useful. The GDG identified six areas where the potential impact of alternative strategies could be substantial and where the health economics evidence should focus. These were: screening for asymptomatic bacteriuria, screening for group B streptococcus, screening for syphilis, screening for sickle cell and thalassaemia, ultrasound screening for structural abnormalities and Down's syndrome screening. For all these topics, a review of the economic evidence was undertaken, followed by simple economic modelling of the cost-effectiveness in England and Wales of different strategies. The review of the economic evaluation studies included cost-effectiveness studies (only those where an ICER had been determined or could be determined from the data presented). The topic had to focus on the appropriate alternatives (the appropriate clinical question), preferably able to be generalised to the England and Wales setting, and therefore be useful in constructing a simple decision model. The review of the evidence included cost-effectiveness studies, costconsequence studies (cost of present and future costs only) and high-quality systematic reviews of the evidence. A narrative review of all the evidence is not presented in the main guideline. Appendices B to F shows the way the models have been constructed, the economic and clinical parameters incorporated into each model, the sources of data that have been used (cost data and clinical data), the results of the baseline model and the sensitivity analysis. Evidence on the cost consequences associated with alternative screening strategies was obtained from various published sources that addressed these issues. The purpose was to obtain goodquality cost data judged by the health economist to be as close as possible to the true opportunity cost of the intervention (screening programme). The key cost variables considered were: the cost of a screening programme (the cost of different screening interventions and the cost of expanding and contracting a screening programme) the cost of treatment of women found to be carriers of a disease the cost of any adverse or non-therapeutic effects of screening or treatment to the woman the cost of the consequences of screening and not screening to the fetus and infant, including fetal loss, ending pregnancy, and the lifetime costs of caring for infants born with disabilities. Cost data not available from published sources were obtained from the most up-to-date NHS reference cost price list. Some cost data could not be obtained from published sources or from NHS reference costs and, in such cases, an indicative estimate of the likely costs was obtained from the GDG. The range of sources of cost data are set out in the appendix that explains the methodology adopted to construct each of the economic models created for this guideline. In some cases (e.g. screening for group B streptococcus and syphilis), the economic modelling work could not be completed owing to lack of clinical evidence relating to the different screening options. Appendices C and D provide some discussion of these models that could not be completed in the guideline and areas for future research.
Limitations of the economic evidence in this guideline
Economic analyses have been undertaken alongside a wide range of antenatal screening procedures. A systematic review of antenatal screening was undertaken in 2001.7 This review found that many of the studies identified were of poor quality, since they did not consider the effects of screening on future health (of mother and baby) but only costs averted by a screening programme. In this guideline, the costs of screening and the costs of the benefits or harm of screening have been considered simultaneously where possible (i.e. where the data exist). It has not been possible
9
Antenatal care
to include many of the consequences of a screening programme because the data do not exist on these less straightforward or measurable outcomes (such as the benefit foregone from ending pregnancy). The economic analysis of screening methods in the guideline has not been able to consider the following: the value to the woman of being given information about the health of her future child the value of being able to plan appropriate services for children who are born with disabilities the value of a life of a child born with disability, to the child, to the family and to society in general the value to a woman of being able to choose whether to end a pregnancy the value of a life foregone as a consequence of screening. The cost-effectiveness studies reviewed for this guideline had narrowly defined endpoints; for example, a case of birth defect detected and subsequently averted as a result of a screening test. Some of the studies have considered the cost consequences of avoiding the birth of an infant with severe disabilities and their long-term care costs. The value of future life foregone (of a healthy or a disabled infant's life) due to screening has not been explicitly considered in any of the economic evidence of antenatal screening. Since economic evaluation should always consider the costs and benefits of an intervention in the widest possible sense, this could be seen as a limitation of the analysis presented in this guideline. The consequences of this are discussed in Appendices B to G as appropriate.
Health economics for the 2008 update
The aim of the economic input into the guideline was to inform the GDG of potential economic issues relating to antenatal care. The health economist helped the GDG by identifying topics within the guideline that might benefit from economic analysis, reviewing the available economic evidence and, where necessary, conducting (or commissioning) economic analysis. Reviews of published health economic evidence are presented alongside the reviews of clinical evidence and are incorporated within the relevant evidence statement and recommendations. For some questions, no published evidence was identified, and decision analytic modelling was undertaken. Results of this modelling are presented in the guideline text where appropriate, with full details in Appendices B to G inclusive. Economic evaluations in this guideline have been conducted in the form of a cost-effectiveness analysis, with the health effects measured in an appropriate non-monetary outcome indicator. The NICE technology appraisal programme measures outcomes in terms of quality-adjusted life years (QALYs). Where possible, this approach has been used in the development of this guideline. However, where it has not been possible to estimate QALYs gained as a result of an intervention, an alternative measure of effectiveness has been used. Cost-effectiveness analysis, with the units of effectiveness expressed in QALYs (known as cost– utility analysis) is widely recognised as a useful approach for measuring and comparing the efficiency of different health interventions. The QALY is a measure of health outcome which assigns to each period of time (generally 1 year) a weight, ranging from 0 to 1, corresponding to health-related quality of life during that period. It is one of the most commonly used outcome measures in health economics. A score of 1 corresponds to full health and a score of 0 corresponds to a health state equivalent to death. Negative valuations, implying a health state worse than death, are possible. Health outcomes using this method are measured by the number of years of life in a given health state multiplied by the value of being in that health state.
2008 update
Forming and grading the recommendations
The GDG was presented with the summaries (text and evidence tables) of the best available research evidence to answer their questions. Recommendations were based on, and explicitly linked to, the evidence that supported them. A recommendation's grade may not necessarily reflect the importance attached to the recommendation. For example, the GDG felt that the principles of
10
Introduction
woman-centred care that underpin this guideline (Chapter 3) are particularly important but some of these recommendations receive only a D grade or good practice point (GPP). The GDG worked where possible on an informal consensus basis. Formal consensus methods (modified Delphi techniques or nominal group technique) were employed if required (e.g. grading recommendations or agreeing audit criteria). The recommendations were then graded according to the level of evidence upon which they were based. The strength of the evidence on which each recommendation is based is shown in Table 1.6. The grading of recommendations will follow that outlined in the Health Technology Assessment (HTA) review How to develop cost conscious guidelines. Table 1.6
Grade A B C D Good practice point (GPP) NICE Technology Appraisal
Strength of the evidence upon which each recommendation is based
Definition Directly based on level I evidence Directly based on level II evidence or extrapolated recommendation from level I evidence Directly based on level III evidence or extrapolated recommendation from either level I or II evidence Directly based on level IV evidence or extrapolated recommendation from either level I, II or III evidence The view of the Guideline Development Group Recommendation taken from a NICE Technology Appraisal
Limited results or data are presented in the text. More comprehensive results and data are available in the relevant evidence tables.
The updated NICE guideline methodology manual (2007)633 requires that recommendations are no longer graded. The 2008 recommendations in this update therefore do not have a grade; however, the grade assigned to 2003 recommendations has been left in place. The Antenatal Assessment Tool was developed using formal consensus methodology (see Chapter 14 for further details).
External review
The guideline has been developed in accordance with the NICE guideline development process.6 This has included the opportunity for registered stakeholders to comment on the scope of the guideline, the first draft of the full and summary guidelines and the second draft of all versions of the guideline. In addition, the first draft was reviewed by nominated individuals with an interest in antenatal care. All drafts, comments and responses were also reviewed by the independent Guideline Review Panel established by NICE. The comments made by the stakeholders, peer reviewers and the NICE Guideline Review Panel were collated and presented anonymously for consideration by the GDG. All comments were considered systematically by the GDG and the resulting actions and responses were recorded.
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Forming and grading the recommendations for the 2008 update
2
Summary of recommendations and care pathway
Key priorities for implementation (key recommendations)
Antenatal information
Pregnant women should be offered information based on the current available evidence together with support to enable them to make informed decisions about their care. This information should include where they will be seen and who will undertake their care.
2.1
Lifestyle considerations
All women should be informed at the booking appointment about the importance for their own and their baby's health of maintaining adequate vitamin D stores during pregnancy and whilst breastfeeding. In order to achieve this, women may choose to take 10 micrograms of vitamin D per day, as found in the Healthy Start multivitamin supplement. Particular care should be taken to enquire as to whether women at greatest risk are following advice to take this daily supplement. These include: women of South Asian, African, Caribbean or Middle Eastern family origin women who have limited exposure to sunlight, such as women who are predominantly housebound, or usually remain covered when outdoors women who eat a diet particularly low in vitamin D, such as women who consume no oily fish, eggs, meat, vitamin D-fortified margarine or breakfast cereal women with a pre-pregnancy body mass index above 30 kg/m.
2008 update
Screening for haematological conditions
Screening for sickle cell diseases and thalassaemias should be offered to all women as early as possible in pregnancy (ideally by 10 weeks). The type of screening depends upon the prevalence and can be carried out in either primary or secondary care.
Screening for fetal anomalies
Participation in regional congenital anomaly registers and/or UK National Screening Committeeapproved audit systems is strongly recommended to facilitate the audit of detection rates. The 'combined test' (nuchal translucency, beta-human chorionic gonadotrophin, pregnancyassociated plasma protein-A) should be offered to screen for Down's syndrome between 11 weeks 0 days and 13 weeks 6 days. For women who book later in pregnancy the most clinically and cost-effective serum screening test (triple or quadruple test) should be offered between 15 weeks 0 days and 20 weeks 0 days.
Screening for clinical conditions
Screening for gestational diabetes using risk factors is recommended in a healthy population. At the booking appointment, the following risk factors for gestational diabetes should be determined: body mass index above 30 kg/m previous macrosomic baby weighing 4.5 kg or above 12
Summary of recommendations and care pathway
previous gestational diabetes (refer to 'Diabetes in pregnancy' [NICE clinical guideline 63], available from www.nice.org.uk/CG063) family history of diabetes (first-degree relative with diabetes) family origin with a high prevalence of diabetes: – South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh) – black Caribbean – Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt). Women with any one of these risk factors should be offered testing for gestational diabetes (refer to 'Diabetes in pregnancy' [NICE clinical guideline 63], available from www.nice.org.uk/CG063).
2.2
Summary of recommendations
Chapter 3 Woman-centred care and informed decision making
Antenatal information Antenatal information should be given to pregnant women according to the following schedule. At the first contact with a healthcare professional: – folic acid supplementation – food hygiene, including how to reduce the risk of a food-acquired infection – lifestyle advice, including smoking cessation, and the implications of recreational drug use and alcohol consumption in pregnancy – all antenatal screening, including screening for haemoglobinopathies, the anomaly scan and screening for Down's syndrome, as well as risks and benefits of the screening tests. At booking (ideally by 10 weeks): – how the baby develops during pregnancy – nutrition and diet, including vitamin D supplementation for women at risk of vitamin D deficiency, and details of the 'Healthy Start' programme (www.healthystart.nhs.uk) – exercise, including pelvic floor exercises – place of birth (refer to 'Intrapartum care' [NICE clinical guideline 55], available from www.nice.org.uk/CG055) – pregnancy care pathway – breastfeeding, including workshops – participant-led antenatal classes – further discussion of all antenatal screening – discussion of mental health issues (refer to 'Antenatal and postnatal mental health' [NICE clinical guideline 45], available from www.nice.org.uk/CG045). Before or at 36 weeks: – breastfeeding information, including technique and good management practices that would help a woman succeed, such as detailed in the UNICEF 'Baby Friendly Initiative' (www.babyfriendly.org.uk) – preparation for labour and birth, including information about coping with pain in labour and the birth plan – recognition of active labour – care of the new baby – vitamin K prophylaxis – newborn screening tests – postnatal self-care – awareness of 'baby blues' and postnatal depression. At 38 weeks: – options for management of prolonged pregnancy. This can be supported by information such as 'The pregnancy book' (Department of Health 2007) and the use of other relevant resources such as UK National Screening Committee publications and the Midwives Information and Resource Service (MIDIRS) information leaflets (www.infochoice.org).
The clinical guideline 'Induction of labour' is being updated and is expected to be published in June 2008.
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Antenatal care
Information should be given in a form that is easy to understand and accessible to pregnant women with additional needs, such as physical, sensory or learning disabilities, and to pregnant women who do not speak or read English. Information can also be given in other forms such as audiovisual or touch screen technology; this should be supported by written information. Pregnant women should be offered information based on the current available evidence together with support to enable them to make informed decisions about their care. This information should include where they will be seen and who will undertake their care. At each antenatal appointment, healthcare professionals should offer consistent information and clear explanations, and should provide pregnant women with an opportunity to discuss issues and ask questions. Pregnant women should be offered opportunities to attend participant-led antenatal classes, including breastfeeding workshops. Women's decisions should be respected, even when this is contrary to the views of the healthcare professional. Pregnant women should be informed about the purpose of any test before it is performed. The healthcare professional should ensure the woman has understood this information and has sufficient time to make an informed decision. The right of a woman to accept or decline a test should be made clear. Information about antenatal screening should be provided in a setting where discussion can take place; this may be in a group setting or on a one-to-one basis. This should be done before the booking appointment. Information about antenatal screening should include balanced and accurate information about the condition being screened for.
2008 update
Chapter 4 Provision and organisation of care
4.1 Who provides care Midwife- and GP-led models of care should be offered for women with an uncomplicated pregnancy. Routine involvement of obstetricians in the care of women with an uncomplicated pregnancy at scheduled times does not appear to improve perinatal outcomes compared with involving obstetricians when complications arise. [A] 4.2 Continuity of care Antenatal care should be provided by a small group of carers with whom the woman feels comfortable. There should be continuity of care throughout the antenatal period. [A] A system of clear referral paths should be established so that pregnant women who require additional care are managed and treated by the appropriate specialist teams when problems are identified. [D] 4.3 Where should antenatal appointments take place Antenatal care should be readily and easily accessible to all women and should be sensitive to the needs of individual women and the local community. [C] The environment in which antenatal appointments take place should enable women to discuss sensitive issues such as domestic violence, sexual abuse, psychiatric illness and illicit drug use. [Good practice point] 4.4 Documentation of care Structured maternity records should be used for antenatal care. [A] Maternity services should have a system in place whereby women carry their own case notes. [A] A standardised, national maternity record with an agreed minimum data set should be developed and used. This will help carers to provide the recommended evidence-based care to pregnant women. [Good practice point] 14
Summary of recommendations and care pathway
4.5 Frequency of antenatal appointments A schedule of antenatal appointments should be determined by the function of the appointments. For a woman who is nulliparous with an uncomplicated pregnancy, a schedule of ten appointments should be adequate. For a woman who is parous with an uncomplicated pregnancy, a schedule of seven appointments should be adequate. [B] Early in pregnancy, all women should receive appropriate written information about the likely number, timing and content of antenatal appointments associated with different options of care and be given an opportunity to discuss this schedule with their midwife or doctor. [D] Each antenatal appointment should be structured and have focused content. Longer appointments are needed early in pregnancy to allow comprehensive assessment and discussion. Wherever possible, appointments should incorporate routine tests and investigations to minimise inconvenience to women. [D] 4.6 Gestational age assessment: LMP and ultrasound Pregnant women should be offered an early ultrasound scan between 10 weeks 0 days and 13 weeks 6 days to determine gestational age and to detect multiple pregnancies. This will ensure consistency of gestational age assessment and reduce the incidence of induction of labour for prolonged pregnancy. Crown–rump length measurement should be used to determine gestational age. If the crown–rump length is above 84 mm, the gestational age should be estimated using head circumference.
Chapter 5 Lifestyle considerations
5.3 Working during pregnancy Pregnant women should be informed of their maternity rights and benefits. [C] The majority of women can be reassured that it is safe to continue working during pregnancy. Further information about possible occupational hazards during pregnancy is available from the Health and Safety Executive (www.hse.gov.uk). [D] A woman's occupation during pregnancy should be ascertained to identify those at increased risk through occupational exposure. [Good practice point] 5.5 Nutritional supplements Pregnant women (and those intending to become pregnant) should be informed that dietary supplementation with folic acid, before conception and up to 12 weeks of gestation, reduces the risk of having a baby with neural tube defects (anencephaly, spina bifida). The recommended dose is 400 micrograms per day. [A] Iron supplementation should not be offered routinely to all pregnant women. It does not benefit the mother's or the fetus's health and may have unpleasant maternal side effects. [A] Pregnant women should be informed that vitamin A supplementation (intake greater than 700 micrograms) might be teratogenic and therefore it should be avoided. Pregnant women should be informed that as liver and liver products may also contain high levels of vitamin A, consumption of these products should also be avoided. [C] All women should be informed at the booking appointment about the importance for their own and their baby's health of maintaining adequate vitamin D stores during pregnancy and whilst breastfeeding. In order to achieve this, women may choose to take 10 micrograms of vitamin D per day, as found in the Healthy Start multivitamin supplement. Particular care should be taken to enquire as to whether women at greatest risk are following advice to take this daily supplement. These include: women of South Asian, African, Caribbean or Middle Eastern family origin women who have limited exposure to sunlight, such as women who are predominantly housebound, or usually remain covered when outdoors women who eat a diet particularly low in vitamin D, such as women who consume no oily fish, eggs, meat, vitamin D-fortified margarine or breakfast cereal women with a pre-pregnancy body mass index above 30 kg/m. 15
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Antenatal care
5.6 Food-acquired infections Pregnant women should be offered information on how to reduce the risk of listeriosis by: drinking only pasteurised or UHT milk not eating ripened soft cheese such as Camembert, Brie and blue-veined cheese (there is no risk with hard cheeses, such as Cheddar, or cottage cheese and processed cheese) not eating pté (of any sort, including vegetable) not eating uncooked or undercooked ready-prepared meals. [D] Pregnant women should be offered information on how to reduce the risk of salmonella infection by: avoiding raw or partially cooked eggs or food that may contain them (such as mayonnaise) avoiding raw or partially cooked meat, especially poultry. [D] 5.7 Prescribed medicines Few medicines have been established as safe to use in pregnancy. Prescription medicines should be used as little as possible during pregnancy and should be limited to circumstances where the benefit outweighs the risk. [D] 5.8 Over-the-counter medicines Pregnant women should be informed that few over-the-counter (OTC) medicines have been established as being safe to take in pregnancy. OTC medicines should be used as little as possible during pregnancy. [D] 5.9 Complementary therapies Pregnant women should be informed that few complementary therapies have been established as being safe and effective during pregnancy. Women should not assume that such therapies are safe and they should be used as little as possible during pregnancy. [D] 5.10 Exercise in pregnancy Pregnant women should be informed that beginning or continuing a moderate course of exercise during pregnancy is not associated with adverse outcomes. [A] Pregnant women should be informed of the potential dangers of certain activities during pregnancy, for example, contact sports, high-impact sports and vigorous racquet sports that may involve the risk of abdominal trauma, falls or excessive joint stress, and scuba diving, which may result in fetal birth defects and fetal decompression disease. [D] 5.11 Sexual intercourse in pregnancy Pregnant woman should be informed that sexual intercourse in pregnancy is not known to be associated with any adverse outcomes. [B] 5.12 Alcohol and smoking in pregnancy Alcohol consumption in pregnancy: Pregnant women and women planning a pregnancy should be advised to avoid drinking alcohol in the first 3 months of pregnancy if possible because it may be associated with an increased risk of miscarriage. If women choose to drink alcohol during pregnancy they should be advised to drink no more than 1 to 2 UK units once or twice a week (1 unit equals half a pint of ordinary strength lager or beer, or one shot [25 ml] of spirits. One small [125 ml] glass of wine is equal to 1.5 UK units). Although there is uncertainty regarding a safe level of alcohol consumption in pregnancy, at this low level there is no evidence of harm to the unborn baby. Women should be informed that getting drunk or binge drinking during pregnancy (defined as more than 5 standard drinks or 7.5 UK units on a single occasion) may be harmful to the unborn baby. Smoking in pregnancy: At the first contact with the woman, discuss her smoking status, provide information about the risks of smoking to the unborn child and the hazards of exposure to secondhand smoke. Address any concerns she and her partner or family may have about stopping smoking.
This recommendation is from the NICE public health guidance on smoking cessation (www.nice.org.uk/PH010). Following NICE protocol, the recommendation has been incorporated verbatim into this guideline.
2008 update
16
Summary of recommendations and care pathway
Pregnant women should be informed about the specific risks of smoking during pregnancy (such as the risk of having a baby with low birthweight and preterm birth). The benefits of quitting at any stage should be emphasised. [A] Offer personalised information, advice and support on how to stop smoking. Encourage pregnant women to use local NHS Stop Smoking Services and the NHS pregnancy smoking helpline, by providing details on when, where and how to access them. Consider visiting pregnant women at home if it is difficult for them to attend specialist services. Monitor smoking status and offer smoking cessation advice, encouragement and support throughout the pregnancy and beyond. Discuss the risks and benefits of nicotine replacement therapy (NRT) with pregnant women who smoke, particularly those who do not wish to accept the offer of help from the NHS Stop Smoking Service. If a woman expresses a clear wish to receive NRT, use professional judgement when deciding whether to offer a prescription. Advise women using nicotine patches to remove them before going to bed. This supersedes NICE technology appraisal guidance 39 on NRT and bupropion. Women who are unable to quit smoking during pregnancy should be encouraged to reduce smoking. [B] 5.13 Cannabis use in pregnancy The direct effects of cannabis on the fetus are uncertain but may be harmful. Cannabis use is associated with smoking, which is known to be harmful; therefore women should be discouraged from using cannabis during pregnancy. [C] 5.14 Air travel during pregnancy Pregnant women should be informed that long-haul air travel is associated with an increased risk of venous thrombosis, although whether or not there is additional risk during pregnancy is unclear. In the general population, wearing correctly fitted compression stockings is effective at reducing the risk. [B] 5.15 Car travel during pregnancy Pregnant women should be informed about the correct use of seatbelts (that is, three-point seatbelts 'above and below the bump, not over it'). [B] 5.16 Travelling abroad during pregnancy Pregnant women should be informed that, if they are planning to travel abroad, they should discuss considerations such as flying, vaccinations and travel insurance with their midwife or doctor. [Good practice point]
Chapter 6 Management of common symptoms of pregnancy
6.1 Nausea and vomiting in early pregnancy Women should be informed that most cases of nausea and vomiting in pregnancy will resolve spontaneously within 16 to 20 weeks of gestation and that nausea and vomiting are not usually associated with a poor pregnancy outcome. If a woman requests or would like to consider treatment, the following interventions appear to be effective in reducing symptoms [A]: nonpharmacological: – ginger – P6 (wrist) acupressure pharmacological: – antihistamines. Information about all forms of self-help and nonpharmacological treatments should be made available for pregnant women who have nausea and vomiting. [Good practice point]
This recommendation is from the NICE public health guidance on smoking cessation (www.nice.org.uk/PH010). Following NICE protocol, the recommendation has been incorporated verbatim into this guideline.
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Antenatal care
6.2 Heartburn Women who present with symptoms of heartburn in pregnancy should be offered information regarding lifestyle and diet modification. [Good practice point] Antacids may be offered to women whose heartburn remains troublesome despite lifestyle and diet modification. [A] 6.3 Constipation Women who present with constipation in pregnancy should be offered information regarding diet modification, such as bran or wheat fibre supplementation. [A] 6.4 Haemorrhoids In the absence of evidence of the effectiveness of treatments for haemorrhoids in pregnancy, women should be offered information concerning diet modification. If clinical symptoms remain troublesome, standard haemorrhoid creams should be considered. [Good practice point] 6.5 Varicose veins Women should be informed that varicose veins are a common symptom of pregnancy that will not cause harm and that compression stockings can improve the symptoms but will not prevent varicose veins from emerging. [A] 6.6 Vaginal discharge Women should be informed that an increase in vaginal discharge is a common physiological change that occurs during pregnancy. If this is associated with itch, soreness, offensive smell or pain on passing urine there maybe an infective cause and investigation should be considered. [Good practice point] A 1 week course of a topical imidazole is an effective treatment and should be considered for vaginal candidiasis infections in pregnant women. [A] The effectiveness and safety of oral treatments for vaginal candidiasis in pregnancy is uncertain and these should not be offered. [Good practice point] 6.7 Backache Women should be informed that exercising in water, massage therapy and group or individual back care classes might help to ease backache during pregnancy. [A]
Chapter 7 Clinical examination of pregnant women
7.1 Measurement of weight and body mass index Maternal weight and height should be measured at the first antenatal appointment, and the woman's body mass index (BMI) calculated (weight [kg]/height[m]). [B] Repeated weighing during pregnancy should be confined to circumstances where clinical management is likely to be influenced. [C] 7.2 Breast examination Routine breast examination during antenatal care is not recommended for the promotion of postnatal breastfeeding. [A] 7.3 Pelvic examination Routine antenatal pelvic examination does not accurately assess gestational age, nor does it accurately predict preterm birth or cephalopelvic disproportion. It is not recommended. [B] 7.4 Female genital mutilation Pregnant women who have had female genital mutilation should be identified early in antenatal care through sensitive enquiry. Antenatal examination will then allow planning of intrapartum care. [C] 7.5 Domestic violence Healthcare professionals need to be alert to the symptoms or signs of domestic violence and women should be given the opportunity to disclose domestic violence in an environment in which they feel secure. [D] 18
Summary of recommendations and care pathway
7.6 Prediction, detection and initial management of mental disorders In all communications (including initial referral) with maternity services, healthcare professionals should include information on any relevant history of mental disorder. At a woman's first contact with services in both the antenatal and the postnatal periods, healthcare professionals (including midwives, obstetricians, health visitors and GPs) should ask about: past or present severe mental illness including schizophrenia, bipolar disorder, psychosis in the postnatal period and severe depression previous treatment by a psychiatrist/specialist mental health team, including inpatient care a family history of perinatal mental illness. Other specific predictors, such as poor relationships with her partner, should not be used for the routine prediction of the development of a mental disorder. At a woman's first contact with primary care, at her booking visit and postnatally (usually at 4 to 6 weeks and 3 to 4 months), healthcare professionals (including midwives, obstetricians, health visitors and GPs) should ask two questions to identify possible depression. During the past month, have you often been bothered by feeling down, depressed or hopeless During the past month, have you often been bothered by having little interest or pleasure in doing things A third question should be considered if the woman answers 'yes' to either of the initial questions. Is this something you feel you need or want help with After identifying a possible mental disorder in a woman during pregnancy or the postnatal period, further assessment should be considered, in consultation with colleagues if necessary. If the healthcare professional or the woman has significant concerns, the woman should normally be referred for further assessment to her GP. If the woman has, or is suspected to have, a severe mental illness (for example, bipolar disorder or schizophrenia), she should be referred to a specialist mental health service, including, if appropriate, a specialist perinatal mental health service. This should be discussed with the woman and preferably with her GP. The woman's GP should be informed in all cases in which a possible current mental disorder or a history of significant mental disorder is detected, even if no further assessment or referral is made.
Chapter 8 Screening for haematological conditions
8.1 Anaemia Pregnant women should be offered screening for anaemia. Screening should take place early in pregnancy (at the booking appointment) and at 28 weeks when other blood screening tests are being performed. This allows enough time for treatment if anaemia is detected. [B] Haemoglobin levels outside the normal UK range for pregnancy (that is, 11 g/100 ml at first contact and 10.5 g/100 ml at 28 weeks) should be investigated and iron supplementation considered if indicated. [A] 8.2 Blood grouping and red cell alloantibodies Women should be offered testing for blood group and rhesus D status in early pregnancy. [B] It is recommended that routine antenatal anti-D prophylaxis is offered to all non-sensitised pregnant women who are rhesus D-negative. [NICE 2002] Women should be screened for atypical red cell alloantibodies in early pregnancy and again at 28 weeks, regardless of their rhesus D status. [B]
This recommendation is from the NICE clinical guideline on antenatal and postnatal mental health (see www.nice.org.uk/CG045). Following NICE protocol, the recommendation has been incorporated verbatim into this guideline. The technology appraisal guidance 'Guidance on the use of routine antenatal anti-D prophylaxis for RhD-negative women' (NICE technology appraisal 41) is being updated and is expected to be published in June 2008.
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2008 update
Antenatal care
Pregnant women with clinically significant atypical red cell alloantibodies should be offered referral to a specialist centre for further investigation and advice on subsequent antenatal management. [D] If a pregnant woman is rhesus D-negative, consideration should be given to offering partner testing to determine whether the administration of anti-D prophylaxis is necessary. [Good practice point] 8.3 Haemoglobinopathies Preconception counselling (supportive listening, advice giving and information) and carrier testing should be available to all women who are identified as being at higher risk of haemoglobinopathies, using the Family Origin Questionnaire from the NHS Antenatal and Newborn Screening Programme (www.sickleandthal.org.uk/Documents/F_Origin_Questionnaire.pdf) (see Appendix J). Information about screening for sickle cell diseases and thalassaemias, including carrier status and the implications of these, should be given to pregnant women at the first contact with a healthcare professional. Refer to Section 3.3 for more information about giving antenatal information. Screening for sickle cell diseases and thalassaemias should be offered to all women as early as possible in pregnancy (ideally by 10 weeks). The type of screening depends upon the prevalence and can be carried out in either primary or secondary care. Where prevalence of sickle cell disease is high (fetal prevalence above 1.5 cases per 10 000 pregnancies), laboratory screening (preferably high-performance liquid chromatography) should be offered to all pregnant women to identify carriers of sickle cell disease and/or thalassaemia. Where prevalence of sickle cell disease is low (fetal prevalence 1.5 cases per 10 000 pregnancies or below), all pregnant women should be offered screening for haemoglobinopathies using the Family Origin Questionnaire (www.sickleandthal.org.uk/Documents/F_Origin_Questionnaire.pdf). If the Family Origin Questionnaire indicates a high risk of sickle cell disorders, laboratory screening (preferably high-performance liquid chromatography) should be offered. If the mean corpuscular haemoglobin is below 27 picograms, laboratory screening (preferably high-performance liquid chromatography) should be offered.
2008 update
If the woman is identified as a carrier of a clinically significant haemoglobinopathy then the father of the baby should be offered counselling and appropriate screening without delay. For more details about haemoglobinopathy variants refer to the NHS Antenatal and Newborn Screening Programme (www.sickleandthal.org.uk/Documents/ProgrammeSTAN.pdf).
Chapter 9 Screening for fetal anomalies
9.1 Screening for structural anomalies Ultrasound screening for fetal anomalies should be routinely offered, normally between 18 weeks 0 days and 20 weeks 6 days. At the first contact with a healthcare professional, women should be given information about the purpose and implications of the anomaly scan to enable them to make an informed choice as to whether or not to have the scan. The purpose of the scan is to identify fetal anomalies and allow: reproductive choice (termination of pregnancy) parents to prepare (for any treatment/disability/palliative care/termination of pregnancy) managed birth in a specialist centre intrauterine therapy.
Women should be informed of the limitations of routine ultrasound screening and that detection rates vary by the type of fetal anomaly, the woman's body mass index and the position of the unborn baby at the time of the scan. If an anomaly is detected during the anomaly scan pregnant women should be informed of the findings to enable them to make an informed choice as to whether they wish to continue with the pregnancy or have a termination of pregnancy. Fetal echocardiography involving the four chamber view of the fetal heart and outflow tracts is recommended as part of the routine anomaly scan. 20
Summary of recommendations and care pathway
Routine screening for cardiac anomalies using nuchal translucency is not recommended. When routine ultrasound screening is performed to detect neural tube defects, alpha-fetoprotein testing is not required. Participation in regional congenital anomaly registers and/or UK National Screening Committeeapproved audit systems is strongly recommended to facilitate the audit of detection rates. 9.2 Screening for Down's syndrome All pregnant women should be offered screening for Down's syndrome. Women should understand that it is their choice to embark on screening for Down's syndrome. Screening for Down's syndrome should be performed by the end of the first trimester (13 weeks 6 days), but provision should be made to allow later screening (which could be as late as 20 weeks 0 days) for women booking later in pregnancy. The 'combined test' (nuchal translucency, beta-human chorionic gonadotrophin, pregnancyassociated plasma protein-A) should be offered to screen for Down's syndrome between 11 weeks 0 days and 13 weeks 6 days. For women who book later in pregnancy the most clinically and cost-effective serum screening test (triple or quadruple test) should be offered between 15 weeks 0 days and 20 weeks 0 days. When it is not possible to measure nuchal translucency, owing to fetal position or raised body mass index, women should be offered serum screening (triple or quadruple test) between 15 weeks 0 days and 20 weeks 0 days.
the screening pathway for both screen-positive and screen-negative results the decisions that need to be made at each point along the pathway and their consequences the fact that screening does not provide a definitive diagnosis and a full explanation of the risk score obtained following testing information about chorionic villus sampling and amniocentesis balanced and accurate information about Down's syndrome. If a woman receives a screen-positive result for Down's syndrome, she should have rapid access to appropriate counselling by trained staff. The routine anomaly scan (at 18 weeks 0 days to 20 weeks 6 days) should not be routinely used for Down's syndrome screening using soft markers The presence of an isolated soft marker, with an exception of increased nuchal fold, on the routine anomaly scan, should not be used to adjust the a priori risk for Down's syndrome. The presence of an increased nuchal fold (6 mm or above) or two or more soft markers on the routine anomaly scan should prompt the offer of a referral to a fetal medicine specialist or an appropriate healthcare professional with a special interest in fetal medicine.
Chapter 10 Screening for infections
10.1 Asymptomatic bacteriuria Women should be offered routine screening for asymptomatic bacteriuria by midstream urine culture early in pregnancy. Identification and treatment of asymptomatic bacteriuria reduces the risk of pyelonephritis. 10.2 Asymptomatic bacterial vaginosis Pregnant women should not be offered routine screening for bacterial vaginosis because the evidence suggests that the identification and treatment of asymptomatic bacterial vaginosis does not lower the risk for preterm birth and other adverse reproductive outcomes. [A]
21
2008 update
Information about screening for Down's syndrome should be given to pregnant women at the first contact with a healthcare professional. This will provide the opportunity for further discussion before embarking on screening. (Refer to Section 3.3 for more information about giving antenatal information). Specific information should include:
Antenatal care
2008 update
10.3 Chlamydia trachomatis At the booking appointment, healthcare professionals should inform pregnant women younger than 25 years about the high prevalence of chlamydia infection in their age group, and give details of their local National Chlamydia Screening Programme (www.chlamydiascreening.nhs.uk). Chlamydia screening should not be offered as part of routine antenatal care. 10.4 Cytomegalovirus The available evidence does not support routine cytomegalovirus screening in pregnant women and it should not be offered. [B] 10.5 Hepatitis B virus Serological screening for hepatitis B virus should be offered to pregnant women so that effective postnatal intervention can be offered to infected women to decrease the risk of mother-to-child transmission. [A] 10.6 Hepatitis C virus Pregnant women should not be offered routine screening for hepatitis C virus because there is insufficient evidence to support its effectiveness and cost-effectiveness.[C] 10.7 HIV Pregnant women should be offered screening for HIV infection early in antenatal care because appropriate antenatal interventions can reduce mother-to-child transmission of HIV infection. [A] A system of clear referral paths should be established in each unit or department so that pregnant women who are diagnosed with an HIV infection are managed and treated by the appropriate specialist teams. [D] 10.8 Rubella Rubella susceptibility screening should be offered early in antenatal care to identify women at risk of contracting rubella infection and to enable vaccination in the postnatal period for the protection of future pregnancies. [B] 10.9 Streptococcus Group B Pregnant women should not be offered routine antenatal screening for group B streptococcus because evidence of its clinical and cost-effectiveness remains uncertain. [C] 10.10 Syphilis Screening for syphilis should be offered to all pregnant women at an early stage in antenatal care because treatment of syphilis is beneficial to the mother and baby. [B] Because syphilis is a rare condition in the UK and a positive result does not necessarily mean that a woman has syphilis, clear paths of referral for the management of pregnant women testing positive for syphilis should be established. [Good practice point] 10.11 Toxoplasmosis Routine antenatal serological screening for toxoplasmosis should not be offered because the risks of screening may outweigh the potential benefits. [B] Pregnant women should be informed of primary prevention measures to avoid toxoplasmosis infection, such as: washing hands before handling food thoroughly washing all fruit and vegetables, including ready-prepared salads, before eating thoroughly cooking raw meats and ready-prepared chilled meals wearing gloves and thoroughly washing hands after handling soil and gardening avoiding cat faeces in cat litter or in soil. [C]
22
Summary of recommendations and care pathway
Chapter 11 Screening for clinical conditions
11.1 Gestational diabetes Screening for gestational diabetes using risk factors is recommended in a healthy population. At the booking appointment, the following risk factors for gestational diabetes should be determined: body mass index above 30 kg/m previous macrosomic baby weighing 4.5 kg or above previous gestational diabetes (refer to 'Diabetes in pregnancy' [NICE clinical guideline 63], available from www.nice.org.uk/CG063) family history of diabetes (first-degree relative with diabetes) family origin with a high prevalence of diabetes: – South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh) – black Caribbean – Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt). Women with any one of these risk factors should be offered testing for gestational diabetes (refer to 'Diabetes in pregnancy' [NICE clinical guideline 63], available from www.nice.org.uk/CG063). In order to make an informed decision about screening and testing for gestational diabetes, women should be informed that: in most women, gestational diabetes will respond to changes in diet and exercise some women (between 10% and 20%) will need oral hypoglycaemic agents or insulin therapy if diet and exercise are not effective in controlling gestational diabetes if gestational diabetes is not detected and controlled there is a small risk of birth complications such as shoulder dystocia a diagnosis of gestational diabetes may lead to increased monitoring and interventions during both pregnancy and labour. Screening for gestational diabetes using fasting plasma glucose, random blood glucose, glucose challenge test and urinalysis for glucose should not be undertaken. 11.2 Pre-eclampsia Blood pressure measurement and urinalysis for protein should be carried out at each antenatal visit to screen for pre-eclampsia. At the booking appointment, the following risk factors for pre-eclampsia should be determined: age 40 years or older nulliparity pregnancy interval of more than 10 years family history of pre-eclampsia previous history of pre-eclampsia body mass index 30 kg/m or above pre-existing vascular disease such as hypertension pre-existing renal disease multiple pregnancy.
More frequent blood pressure measurements should be considered for pregnant women who have any of the above risk factors. The presence of significant hypertension and/or proteinuria should alert the healthcare professional to the need for increased surveillance. Blood pressure should be measured as outlined below: remove tight clothing, ensure arm is relaxed and supported at heart level use cuff of appropriate size inflate cuff to 20–30 mmHg above palpated systolic blood pressure lower column slowly, by 2 mmHg per second or per beat read blood pressure to the nearest 2 mmHg measure diastolic blood pressure as disappearance of sounds (phase V). 23
2008 update
Antenatal care
Hypertension in which there is a single diastolic blood pressure of 110 mmHg or two consecutive readings of 90 mmHg at least 4 hours apart and/or significant proteinuria (1+) should prompt increased surveillance. If the systolic blood pressure is above 160 mmHg on two consecutive readings at least 4 hours apart, treatment should be considered. All pregnant women should be made aware of the need to seek immediate advice from a healthcare professional if they experience symptoms of preeclampsia. Symptoms include: severe headache problems with vision, such as blurring or flashing before the eyes severe pain just below the ribs vomiting sudden swelling of the face, hands or feet.
2008 update
Although there is a great deal of material published on alternative screening methods for preeclampsia, none of these has satisfactory sensitivity and specificity, and therefore they are not recommended. 11.3 Preterm birth Routine screening for preterm labour should not be offered. 11.4 Placenta praevia Because most lowlying placentas detected at the routine anomaly scan will have resolved by the time the baby is born, only a woman whose placenta extends over the internal cervical os should be offered another transabdominal scan at 32 weeks. If the transabdominal scan is unclear, a transvaginal scan should be offered.
Chapter 12 Fetal growth and wellbeing
Determining fetal growth Symphysis–fundal height should be measured and recorded at each antenatal appointment from 24 weeks. Ultrasound estimation of fetal size for suspected largeforgestationalage unborn babies should not be undertaken in a lowrisk population. Routine Doppler ultrasound should not be used in lowrisk pregnancies. Abdominal palpation for fetal presentation Fetal presentation should be assessed by abdominal palpation at 36 weeks or later, when presentation is likely to influence the plans for the birth. Routine assessment of presentation by abdominal palpation should not be offered before 36 weeks because it is not always accurate and may be uncomfortable. [C] Suspected fetal malpresentation should be confirmed by an ultrasound assessment. [Good practice point] Routine monitoring of fetal movements Routine formal fetalmovement counting should not be offered. [A] Auscultation of fetal heart Auscultation of the fetal heart may confirm that the fetus is alive but is unlikely to have any predictive value and routine listening is therefore not recommended. However, when requested by the mother, auscultation of the fetal heart may provide reassurance. [D] Cardiotocography The evidence does not support the routine use of antenatal electronic fetal heart rate monitoring (cardiotocography) for fetal assessment in women with an uncomplicated pregnancy and therefore it should not be offered. [A]
24
Summary of recommendations and care pathway
Ultrasound assessment in the third trimester The evidence does not support the routine use of ultrasound scanning after 24 weeks of gestation and therefore it should not be offered. [A]
Chapter 13 Management of specific clinical conditions
13.1 Pregnancy after 41 weeks (see also Section 4.6 Gestational age assessment) Prior to formal induction of labour,* women should be offered a vaginal examination for membrane sweeping. [A] Women with uncomplicated pregnancies should be offered induction of labour* beyond 41 weeks. [A] From 42 weeks, women who decline induction of labour should be offered increased antenatal monitoring consisting of at least twiceweekly cardiotocography and ultrasound estimation of maximum amniotic pool depth. [Good practice point] 13.2 Breech presentation at term All women who have an uncomplicated singleton breech pregnancy at 36 weeks should be offered external cephalic version. Exceptions include women in labour and women with a uterine scar or abnormality, fetal compromise, ruptured membranes, vaginal bleeding and medical conditions. [A] Where it is not possible to schedule an appointment for external cephalic version at 37 weeks, it should be scheduled at 36 weeks. [Good practice point]
2.3
Key priorities for research
Information for pregnant women
Alternative ways of helping healthcare professionals to support pregnant women in making informed decisions should be investigated. Why this is important Giving pregnant women relevant information to allow them to make an informed decision remains a challenge to all healthcare professionals. The use of media other than leaflets needs to be systematically studied, and the current available evidence is limited.
Vitamin D 2008 update
There is a need for research into the effectiveness of routine vitamin D supplementation for pregnant and breastfeeding women. Why this is important Although there is some evidence of benefit from vitamin D supplementation for pregnant women at risk of vitamin D deficiency, there is less evidence in the case of pregnant women currently regarded as being at low risk of deficiency. It is possible that there will be health gains resulting from vitamin D supplementation, but further evidence is required.
Chlamydia screening
Further research needs to be undertaken to assess the effectiveness, practicality and acceptability of chlamydia screening in an antenatal setting. Why this is important Chlamydia is a significant healthcare issue, especially amongst the young, but the current level of evidence provides an insufficient basis for a recommendation. Of particular importance is the possibility that treatment might reduce the incidence of preterm birth and neonatal complications, and studies should be directed to these areas.
* The clinical guideline 'Induction of labour' is being updated and is expected to be published in June 2008.
25
Antenatal care
Fetal growth and wellbeing
Further prospective research is required to evaluate the diagnostic value and effectiveness (both clinical and cost-effectiveness) of predicting small-for-gestational-age babies using: customised fetal growth charts to plot symphysis–fundal height measurements routine ultrasound in the third trimester. Why this is important Poor fetal growth is undoubtedly a cause of serious perinatal mortality and morbidity. Unfortunately, the methods by which the condition can be identified antenatally are poorly developed or not tested by rigorous methodology. However, existing evidence suggests that there may be ways in which babies at risk can be identified and appropriately managed to improve outcome, and this should form the basis of the study.
The 'Antenatal assessment tool'
Multicentred validation studies are required in the UK to validate and evaluate the use of the 'Antenatal assessment tool'. Using structured questions, the tool aims to support the routine antenatal care of all women by identifying women who may require additional care. The tool identifies women who: can remain within or return to the routine antenatal pathway of care may need additional obstetric care for medical reasons may need social support and/or medical care for a variety of socially complex reasons. Why this is important The idea of some form of assessment tool to help group pregnant women into low-risk (midwiferyonly care) and increased-risk (midwifery and obstetric care) categories is not new. The 'Antenatal assessment tool' has been developed using a consensus approach. Once developed, it will be essential to subject the tool to a multicentred validation study. The validated tool should have the potential to identify a third group of women who are particularly vulnerable and at increased risk of maternal and perinatal death.
2008 update
2.4
2.4.1
Additional research recommendations
2008 recommendations
5.12 Alcohol and smoking in pregnancy Prospective research is required into the effects of alcohol consumption during pregnancy. 9.1 Screening for structural anomalies Research should be undertaken to elucidate the relationship between increased nuchal translucency and cardiac defects. 9.2 Screening for Down's syndrome There should be multicentred studies to evaluate the practicality, cost-effectiveness and acceptability of a two-stage test for Down's syndrome and other screening contingencies including the integrated test. Further research should be undertaken into the views and understanding of women going through the screening process. 11.1 Gestational diabetes Is screening for gestational diabetes based on expected local prevalence, with or without modification by risk factors, clinically effective and cost-effective 11.2 Pre-eclampsia Further research using large prospective studies should be conducted into the effectiveness and cost-effectiveness of using alpha-fetoprotein, beta-human chorionic gonadotrophin, fetal DNA in maternal blood and uterine artery Dopplers or potentially a combination of these, to detect women at risk of developing pre-eclampsia. Testing should focus particularly on the prediction of early-onset pre-eclampsia, with priority given to blood tests.
26
Summary of recommendations and care pathway
11.3 Preterm birth There is need for future research investigating the value of tests that are cheap and easy to perform such as maternal serum human chorionic gonadotrophin (MSHCG), serum C-reactive protein (CRP) and cervico-vaginal fetal fibrinonectin levels. The diagnostic accuracy and costeffectiveness of transvaginal ultrasound to measure cervical length and funnelling to identify women at risk of preterm labour should also be investigated.
2.4.2
2003 recommendations for future research
Antenatal care is fortunate to have some areas where research evidence can clearly underpin clinical practice. However, it is noticeable that there are key areas within care where the research evidence is limited. For some of these areas, such as screening for gestational diabetes and firsttrimester screening for anomalies, research is under way and results are awaited but for others there is an urgent need to address the gaps in the evidence. Effective ways of helping health professionals to support pregnant women in making informed decisions should be investigated. (Chapter 3) There is a lack of qualitative research on women's views regarding who provides care during pregnancy. (4.1) Alternative methods of providing antenatal information and support, such as drop in services, should be explored. (4.5) Research that explores how to ensure women's satisfaction and low morbidity and mortality with a reduced schedule of appointments should be conducted. (4.5) Further research to quantify the risk of air travel and to assess the effectiveness of interventions to prevent venous thromboembolism in pregnancy is needed. (5.14) More information on maternal and fetal safety for all interventions for nausea and vomiting in pregnancy (except antihistamines) is needed. (6.1) Further research into other nonpharmacological treatments for nausea and vomiting in pregnancy is recommended. (6.1) Although many treatments exist for backache in pregnancy, there is a lack of research evaluating their safety and effectiveness. (6.7) More research on effective treatments for symphysis pubis dysfunction is needed. (6.8) There is a lack of research evaluating effective interventions for carpal tunnel syndrome. (6.9) Although there are effective screening tools and screening for domestic violence has been shown to be acceptable to women, there is insufficient evidence on the effectiveness of interventions in improving health outcomes for women who have been identified. Therefore evaluation of interventions for domestic violence is urgently needed. (7.5) Randomised controlled trials are needed to confirm the beneficial effect of screening for asymptomatic bacteriuria. (10.1) Further research into the effectiveness and cost-effectiveness of antenatal screening for streptococcus group B is needed. (10.9) Further research is necessary to determine whether tocolysis improves the success rate of external cephalic version. (13.2)
2.5
Care pathway
The care pathway on pages 28–36 is reproduced from the Quick Reference Guide version of this guideline, which is available at www.nice.org.uk/CG062.
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Antenatal care – care pathway
Women needing additional care
The guideline makes recommendations on baseline clinical care for all pregnant women. Pregnant women with the following conditions usually require additional care:
● ●
cardiac disease, including hypertension renal disease endocrine disorders or diabetes requiring insulin psychiatric disorders (being treated with medication) haematological disorders autoimmune disorders epilepsy requiring anticonvulsant drugs malignant disease severe asthma
●
use of recreational drugs such as heroin, cocaine (including crack cocaine) and ecstasy HIV or HBV infection obesity (body mass index 30 kg/m2 or above) or underweight (body mass index below 18 kg/m2) higher risk of developing complications, for example, women aged 40 and older, women who smoke women who are particularly vulnerable (such as teenagers) or who lack social support.
Women needing additional care
●
● ●
●
● ● ● ● ●
●
●
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8
NICE clinical guideline 62
Quick reference guide
In addition, women who have experienced any of the following in previous pregnancies usually require additional care:
● ● ●
recurrent miscarriage (three or more) preterm birth severe pre-eclampsia, HELLP syndrome or eclampsia rhesus isoimmunisation or other significant blood group antibodies uterine surgery including caesarean section, myomectomy or cone biopsy antenatal or postpartum haemorrhage on two occasions puerperal psychosis
● ● ●
grand multiparity (more than six pregnancies) a stillbirth or neonatal death a small-for-gestational-age infant (below 5th centile) a large-for-gestational-age infant (above 95th centile) a baby weighing below 2.5 kg or above 4.5 kg a baby with a congenital abnormality (structural or chromosomal). Women needing additional care
9
●
●
●
●
●
●
●
NICE clinical guideline 62
Quick reference guide
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Antenatal care – care pathway
Antenatal information
Give information that:
●
is easily understood by all women, including women with additional needs such as physical, sensory or learning disabilities, and women who do not speak or read English enables women to make informed decisions is clear, consistent, balanced and accurate, and based on the current evidence is supported by written information and may also be provided in different formats.
●
Antenatal information
● ●
Remember to:
● ● ● ● ●
respect a woman's decisions, even when her views are contrary to your own provide an opportunity for her to discuss concerns and ask questions make sure she understands the information give her enough time to make decisions explain details of antenatal tests and screening in a setting conducive to discussions (group setting or one-to-one). This should happen before the booking appointment.
Information should cover:
● ● ● ●
where the woman will be seen and who by the likely number, timing and content of antenatal appointments participant-led antenatal classes and breastfeeding workshops the woman's right to accept or decline a test. Antenatal information
The following pages contain details about information to give to pregnant women at specific times during their pregnancy. This information can be supported by 'The pregnancy book', other relevant resources such as UK National Screening Committee publications and the Midwives Information and Resource Service information leaflets (www.infochoice.org).
NICE clinical guideline 62 Quick reference guide 11
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Quick reference guide
Antenatal care – care pathway
Basic principles of antenatal care
Midwives and GPs should care for women with an uncomplicated pregnancy, providing continuous care throughout the pregnancy. Obstetricians and specialist teams should be involved where additional care is needed. Antenatal appointments should take place in a location that women can easily access. The location should be appropriate to the needs of women and their community. Basic principles of antenatal care Maternity records should be structured, standardised, national maternity records, held by the woman. In an uncomplicated pregnancy, there should be 10 appointments for nulliparous women and 7 appointments for parous women. Each antenatal appointment should have a structure and a focus. Appointments early in pregnancy should be longer to provide information and time for discussion about screening so that women can make informed decisions. If possible, incorporate routine tests into the appointments to minimise inconvenience to women. Women should feel able to discuss sensitive issues and disclose problems. Be alert to the symptoms and signs of domestic violence.
2008 update
12
NICE clinical guideline 62
Quick reference guide
Schedule of appointments
First contact with a healthcare professional
Give specific information on: ● folic acid supplements
● ●
food hygiene, including how to reduce the risk of a food-acquired infection lifestyle, including smoking cessation, recreational drug use and alcohol consumption all antenatal screening, including risks, benefits and limitations of the screening tests.
●
Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
For further information about lifestyle see pages 23–25.
NICE clinical guideline 62 Quick reference guide 13
30
Schedule of appointments
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions.
Antenatal care – care pathway
Schedule of appointments
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions. Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
Booking appointment (ideally by 10 weeks)
Checks and tests ● Identify women who may need additional care (see pages 8 and 9) and plan pattern of care for the pregnancy.
● ● ●
Measure height and weight and calculate body mass index. Measure blood pressure and test urine for proteinuria. Determine risk factors for pre-eclampsia and gestational diabetes (refer to 'Diabetes in pregnancy' [NICE clinical guideline 63], available from www.nice.org.uk/CG063). Offer blood tests to check blood group and rhesus D status, and screening for anaemia, haemoglobinopathies, red-cell alloantibodies, hepatitis B virus, HIV, rubella susceptibility and syphilis. Offer screening for asymptomatic bacteriuria. Inform women younger than 25 years about the high prevalence of chlamydia infection in their age group, and give details of their local National Chlamydia Screening Programme. Offer screening for Down's syndrome. Offer early ultrasound scan for gestational age assessment and ultrasound screening for structural anomalies. Identify women who have had genital mutilation (FGM).
Quick reference guide
●
● ●
● ●
●
● ● ●
Ask about any past or present severe mental illness or psychiatric treatment. Ask about mood to identify possible depression. Ask about the woman's occupation to identify potential risks.
Give specific information on: ● how the baby develops during pregnancy
● ● ● ● ● ● ● ●
exercise, including pelvic floor exercises antenatal screening, including risks and benefits of the screening tests the pregnancy care pathway planning place of birth (refer to 'Intrapartum care' [NICE clinical guideline 55]) breastfeeding, including workshops participant-led antenatal classes maternity benefits.
Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
NICE clinical guideline 62
Quick reference guide
15
Schedule of appointments
nutrition and diet, including vitamin D supplements
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions.
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14
NICE clinical guideline 62
Antenatal care – care pathway
Schedule of appointments
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions. Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
For women who choose to have screening, arrange as appropriate: ● blood tests (blood group, rhesus D status, screening for anaemia, haemoglobinopathies, red-cell alloantibodies, hepatitis B virus, HIV, rubella susceptibility and syphilis), ideally before 10 weeks
● ●
urine tests (proteinuria and asymptomatic bacteriuria) ultrasound scan to determine gestational age using: – crown–rump measurement between 10 weeks 0 days and 13 weeks 6 days – head circumference if crown–rump length is above 84 mm Down's syndrome screening using either: – 'combined test' between 11 weeks 0 days and 13 weeks 6 days – serum screening test (triple or quadruple test) between 15 weeks 0 days and 20 weeks 0 days ultrasound screening for structural anomalies, normally between 18 weeks 0 days and 20 weeks 6 days.
●
●
2008 update
16
NICE clinical guideline 62
Quick reference guide
16 weeks
Checks and tests ● Review, discuss and record the results of screening tests.
● ●
Measure blood pressure and test urine for proteinuria. Investigate a haemoglobin level below 11 g/100 ml and consider iron supplements.
Anomaly scan: 18 to 20 weeks
Checks and tests ● If the woman chooses, an ultrasound scan should be performed between 18 weeks 0 days and 20 weeks 6 days to detect structural anomalies.
●
For a woman whose placenta extends across the internal cervical os, offer another scan at 32 weeks.
Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
NICE clinical guideline 62
Quick reference guide
17
32
Schedule of appointments
Give specific information on: ● the routine anomaly scan.
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions.
Antenatal care – care pathway
Schedule of appointments
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions. Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
25 weeks – for nulliparous women
Checks and tests ● Measure blood pressure and test urine for proteinuria.
●
Measure and plot symphysis–fundal height.
28 weeks
Checks and tests ● Measure blood pressure and test urine for proteinuria.
● ●
Offer a second screening for anaemia and atypical red-cell alloantibodies. Investigate a haemoglobin level below 10.5 g/100 ml and consider iron supplements. Offer anti-D prophylaxis to women who are rhesus D-negative1. Measure and plot symphysis–fundal height.
● ●
1
The technology appraisal guidance 'Guidance on the use of routine antenatal anti-D prophylaxis for RhD-negative women' (NICE technology appraisal 41) is being updated and is expected to be published in June 2008.
31 weeks – for nulliparous women
Checks and tests ● Review, discuss and record the results of screening tests undertaken at 28 weeks.
● ●
Measure blood pressure and test urine for proteinuria. Measure and plot symphysis–fundal height.
Checks and tests ● Review, discuss and record the results of screening tests undertaken at 28 weeks.
● ● ●
Measure blood pressure and test urine for proteinuria. Offer a second dose of anti-D prophylaxis to women who are rhesus D-negative1. Measure and plot symphysis–fundal height.
Give specific information on: ● preparation for labour and birth, including the birth plan, recognising active labour and coping with pain.
Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
1
The technology appraisal guidance 'Guidance on the use of routine antenatal anti-D prophylaxis for RhD-negative women' (NICE technology appraisal 41) is being updated and is expected to be published in June 2008.
NICE clinical guideline 62
Quick reference guide
19
Schedule of appointments
34 weeks
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions.
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Quick reference guide
Antenatal care – care pathway
Schedule of appointments
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions. Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
36 weeks
Checks and tests ● Measure blood pressure and test urine for proteinuria.
● ●
Measure and plot symphysis–fundal height. Check the position of the baby. If breech, offer external cephalic version.
Give specific information (at or before 36 weeks) on: ● breastfeeding: technique and good management practices, such as detailed in the UNICEF Baby Friendly Initiative (www.babyfriendly.org.uk)
● ●
care of the new baby, vitamin K prophylaxis and newborn screening tests postnatal self-care, awareness of 'baby blues' and postnatal depression.
38 weeks
Checks and tests ● Measure blood pressure and test urine for proteinuria.
●
Measure and plot symphysis–fundal height.
Give specific information on: ● options for management of prolonged pregnancy2.
2
The clinical guideline 'Induction of labour' is being updated and is expected to be published in June 2008.
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40 weeks – for nulliparous women
Checks and tests ● Measure blood pressure and test urine for proteinuria.
● ●
Measure and plot symphysis–fundal height. Further discussion of management of prolonged pregnancy2.
Checks and tests For women who have not given birth by 41 weeks:
● ● ● ●
offer a membrane sweep2 offer induction of labour2 measure blood pressure and test urine for proteinuria measure and plot symphysis–fundal height.
From 42 weeks, offer women who decline induction of labour increased monitoring (at least twice-weekly cardiotocography and ultrasound examination of maximum amniotic pool depth).
Be alert to any factors, clinical and/or social, that may affect the health of the woman and baby.
2
The clinical guideline 'Induction of labour' is being updated and is expected to be published in June 2008.
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Quick reference guide
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34
Schedule of appointments
41 weeks
Give information (supported by written information and antenatal classes), with an opportunity to discuss issues and ask questions.
Antenatal care – care pathway
Antenatal interventions NOT routinely recommended
● ● ● ●
Repeated maternal weighing. Breast or pelvic examination. Iron or vitamin A supplements. Routine screening for chlamydia, cytomegalovirus, hepatitis C virus, group B streptococcus, toxoplasmosis, bacterial vaginosis. Routine Doppler ultrasound in low-risk pregnancies. Ultrasound estimation of fetal size for suspected large-for-gestational-age unborn babies. Routine screening for preterm labour. Routine screening for cardiac anomalies using nuchal translucency. Gestational diabetes screening using fasting plasma glucose, random blood glucose, glucose challenge test or urinalysis for glucose. Routine fetal-movement counting. Routine auscultation of the fetal heart. Routine antenatal electronic cardiotocography. Routine ultrasound scanning after 24 weeks.
Antenatal interventions NOT routinely recommended
● ● ● ● ●
● ● ● ●
Lifestyle advice
Work Reassure women that it is usually safe to continue working. Ascertain a woman's occupation to identify risk. Refer to the Health and Safety Executive (www.hse.gov.uk) for more information. Tell women about their maternity rights and benefits.
Advise women of the importance of vitamin D intake during pregnancy and breastfeeding (10 micrograms per day). Ensure women at risk of deficiency are following this advice. Do not recommend routine iron supplementation. Advise women of the risk of birth defects associated with vitamin A, and to avoid vitamin A supplementation (above 700 micrograms) and liver products. Avoiding infection Advise women how to reduce the risk of listeriosis and salmonella, and how to avoid toxoplasmosis infection. Medicines Prescribe as few medicines as possible, and only in circumstances where the benefit outweighs the risk. Advise women to use over-the-counter medicines as little as possible.
continued
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Lifestyle advice
Nutritional supplements
Recommend supplementation with folic acid before conception and throughout the first 12 weeks (400 micrograms per day).
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Antenatal care – care pathway
Lifestyle advice
Complementary therapies Exercise Advise women that few complementary therapies have been proven as being safe and effective during pregnancy. There is no risk associated with starting or continuing moderate exercise. However, sports that may cause abdominal trauma, falls or excessive joint stress; and scuba diving, should be avoided. Reassure women that intercourse is thought to be safe during pregnancy. Advise women planning a pregnancy to avoid alcohol in the first 3 months if possible. If women choose to drink alcohol, advise them to drink no more than 1 to 2 UK units once or twice a week (1 unit equals half a pint of ordinary strength lager or beer, or one shot [25 ml] of spirits. One small [125 ml] glass of wine is equal to 1.5 UK units). At this low level there is no evidence of harm. Advise women to avoid getting drunk and to avoid binge drinking. Smoking Discuss smoking status and give information about the risks of smoking during pregnancy. Give information, advice and support on how to stop smoking throughout the pregnancy. Give details of, and encourage women to use, NHS Stop Smoking Services and the NHS pregnancy smoking helpline (0800 169 9 169). Discuss nicotine replacement therapy (NRT). If women are unable to quit, encourage them to reduce smoking.
Lifestyle advice
Sexual intercourse Alcohol
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NICE clinical guideline 62
Quick reference guide
Cannabis Air travel
Discourage women from using cannabis. Long-haul air travel is associated with an increased risk of venous thrombosis, although the possibility of any additional risk in pregnancy is unclear. In the general population, compression stockings are effective in reducing the risk.
Travel abroad
Advise women to discuss flying, vaccinations and travel insurance with their midwife or doctor.
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Quick reference guide
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36
Lifestyle advice
Car travel
Advise women that the seat belt should go 'above and below the bump, not over it'.
3
Woman-centred care and informed decision making
Introduction
Women, their partners and their families should always be treated with kindness, respect and dignity. The views, beliefs and values of the woman, her partner and her family in relation to her care and that of her baby should be sought and respected at all times. Women should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If women do not have the capacity to make decisions, healthcare professionals should follow the Department of Health guidelines – 'Reference guide to consent for examination or treatment' (2001) (available from www.dh.gov.uk). Since April 2007 healthcare professionals need to follow a code of practice accompanying the Mental Capacity Act (summary available from www.dca.gov.uk/menincap/bill-summary.htm). Good communication between healthcare professionals and women is essential. It should be supported by evidence-based, written information tailored to the woman's needs. Treatment and care, and the information women are given about it, should be culturally appropriate. It should also be accessible to women with additional needs such as physical, sensory or learning disabilities, and to women who do not speak or read English. Every opportunity should be taken to provide the woman and her partner or other relevant family members with the information and support they need.
3.1
Clinical question What, how and when information should be offered during the antenatal period to inform women's decisions about care during pregnancy, labour, birth and the postnatal period Previous NICE guidance (for the updated recommendations see below) Pregnant women should offered opportunities to attend antenatal classes and have written information about antenatal care. [A] Pregnant women should be offered evidence-based information and support to enable them to make informed decisions regarding their care. Information should include details of where they will be seen and who will undertake their care. Addressing women's choices should be recognised as being integral to the decision-making process. [C] At the first contact, pregnant women should be offered information about pregnancy care services and options available, lifestyle considerations, including dietary information, and screening tests. [C] Pregnant women should be informed about the purpose of any screening test before it is performed. The right of a woman to accept or decline a test should be made clear. [D] At each antenatal appointment, midwives and doctors should offer consistent information and clear explanations and should provide pregnant women with an opportunity to discuss issues and ask questions. [D] Communication and information should be provided in a form that is accessible to pregnant women who have additional needs, such as those with physical, cognitive or sensory disabilities and those who do not speak or read English. [GPP]
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3.2
Provision of information
Antenatal care
Future research: Effective ways of helping health professionals to support pregnant women in making informed decisions should be investigated.
3.2.1
Introduction and background
Informed decision making involves making reasoned choice based on relevant information about the advantages and disadvantages of all the possible courses of action (including taking no action).8 It requires that the individual has understood both the information provided and the full implications of all the alternative courses of action available. In providing information for women antenatally it is important that healthcare professionals are aware of what informed choice entails and that they provide information in order to facilitate this. The provision of clear information, and time for women to consider decisions and seek additional information, as well as the need for care to be provided in an individualised, woman-focused way are key components of Standard 11 Section 3 of the National Service Framework for Maternity Care (September 2004, www.dh.gov.uk/).
3.2.2
Effectiveness of information giving
Description of included studies Common areas were chosen to search for evidence regarding the effectiveness of information giving. These were chosen either because of their relevance to this guideline update or because they are areas where a body of evidence was known to exist that could be drawn on to illustrate general principles that could inform the clinical question. The areas chosen were breastfeeding information, dietary information, smoking cessation and travel safety. The section on breastfeeding information includes a Cochrane systematic review and a Health Technology Assessment, an RCT, two cluster RCTs, two controlled trials, a prospective cohort study and two descriptive studies. The section on dietary information comprises five studies: a Cochrane systematic review, an RCT, a prospective cohort study, a qualitative study and a retrospective study.
2008 update
3.2.3
Breastfeeding information/preparation
Findings A Cochrane systematic review (2005)637 examined the interventions that aim to encourage women to breastfeed, to evaluate their effectiveness in terms of changes in the number of women who initiate breastfeeding and to report any other effects of such interventions. [EL = 1+] The review included seven randomised controlled trials (RCTs) with or without blinding of any breastfeeding promotion intervention among healthy low-risk pregnant women with healthy infants. There was no limitation of study by country of origin or language. The outcome measure studied was initiation rate of breastfeeding. The seven studies suffered from a high overall risk of bias due to unclear or inadequate allocation concealment. Regarding attrition bias, three of seven studies reported breastfeeding initiation for all participants. The remaining four studies had up to 25% losses to follow up between recruitment and breastfeeding initiation. A total of 1388 women were included. These seven studies were classified and analysed under three types of intervention: health education, breastfeeding promotion packs, and early mother–infant contact. Five trials involving 582 women showed that breastfeeding education had a significant effect on increasing initiation rates compared with routine care (RR 1.53, 95% CI 1.25 to 1.88). These trials evaluated programmes delivered in the USA to low-income women. It was concluded that the forms of intervention evaluated were effective at increasing breastfeeding initiation rates among women on low incomes in the USA. A Health Technology Assessment (2000)638 evaluated the existing evidence to identify which promotion programmes are effective at increasing the number of women who start to breastfeed. [EL = 1+] The review also assessed the impact of such programmes on the duration and exclusivity of breastfeeding. RCTs, non-randomised controlled trials (non-RCTs) with concurrent controls, and before–after studies (cohort and cross-sectional) were included in the review. The study participants included pregnant women, mothers in the immediate postpartum period before the first breastfeed, any participant linked to pregnant women or new mothers, or any participant
38
Woman-centred care and informed decision making
who may breastfeed in the future, or be linked to a breastfeeding woman in the future. The review included any type of intervention designed to promote the uptake of breastfeeding and the control groups could receive an alternative breastfeeding promotion programme or standard care. A total of 59 studies met the selection criteria, out of which 14 were RCTs, 16 non-RCTs and 29 before–after studies. Interventions were grouped into categories: health education; health sector initiatives (HSI) – general; HSI – Baby Friendly Hospital Initiative (BFHI); HSI – training of health professionals; HSI – US Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); HSI – social support from health professionals; peer support; media campaigns; and multifaceted interventions. The health education intervention was covered in nine RCTs, seven non-RCTs and three before–after studies. The result of this intervention showed that there is limited impact on initiation rates of breastfeeding by giving breastfeeding literature alone, or combined with a more formal, non-interactive method of health education. Small, informal, group health education classes, delivered in the antenatal period, can be an effective intervention to increase initiation rates, and in some cases the duration of breastfeeding, among women from different income or ethnic groups. Two RCTs, three non-RCTs and five before–after studies were included in relation to HSI – WIC. It was found that effective WIC interventions included one-to-one health education in the antenatal period, peer counselling in the ante- and postnatal periods, or a combination of one-to-one health education and peer counselling in the ante- and postnatal periods. WIC programmes were effective at increasing both the initiation and duration of breastfeeding among women of low-income groups in the USA. Regarding HSI – training of health professionals, five before–after studies were included. There is limited evidence but it suggests that these programmes may be useful in improving the knowledge of midwives and nurses. There were no favourable results shown in terms of changes in attitudes of health professionals, or changes in breastfeeding rates. There was one RCT on social support intervention and it did not significantly increase rates of initiation compared with standard care. Two non-RCTs were included related to peer support and showed that peer support programmes, when delivered as a stand-alone intervention to women in low-income groups, to be an effective intervention at increasing initiation rates (and duration) among women who had expressed a wish to breastfeed. Two before–after studies were found related to media campaigns which suggested that a media campaign as a stand-alone intervention, and particularly television commercials, may improve attitudes towards and increase initiation rates of breastfeeding. There was one RCT and ten before–after studies related to multifaceted interventions that found that multifaceted interventions comprising a media campaign and/or a peer support programme combined with structural changes to the health sector (HSI) or, in fewer cases, combined with health education activities are effective in increasing initiation rates (and duration and exclusivity of breastfeeding). It was concluded that there is sufficient evidence of effectiveness to increase the availability of good practice health education programmes. A cluster RCT in a teaching hospital in North West of England (2005)639 [EL = 1] assessed the effectiveness of an antenatal educational breastfeeding intervention which attempted to enable woman to achieve their own target for breastfeeding duration. It was delivered by a lactation consultant to both pregnant women and their attendant midwife. The primary outcome was the proportion that fulfilled their antenatal breastfeeding expectation and the secondary outcomes were the number of women breastfeeding on discharge and at 4 months. Women who expressed a desire to breastfeed at the start of their pregnancy were allocated to either routine antenatal education or an additional single educational group session supervised by a lactation specialist and attended by midwives from their locality. Data were collected using a series of questionnaires and diaries. 1312 women were randomised but 1249 (95%) women were available for analysis. The study results found no difference between the groups in the proportion of women who attained their expected duration of breastfeeding (OR 1.2, 95% CI 0.89 to 1.6). There were no differences between the groups in the uptake of breastfeeding on discharge (OR 1.2, 95% CI 0.8 to 1.7) or exclusively at 4 months (OR 1.1, 95% CI 0.6 to 1.8). The intervention was only available antenatally, and it failed to address the emotional and physical needs of women in the postnatal period. The study included women who expressed a desire to breastfeed so the results cannot be generalised to all women. It was not possible to conceal the study group allocation from the recruiting midwife or to blind the women or the attending midwives from the treatment allocation. An RCT conducted in Singapore (2007)640 aimed to address the impact of simple antenatal educational interventions on breastfeeding practice. [EL = 1] Low-risk antenatal women were
39
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Antenatal care
randomly assigned to one of the three groups. Group A received breastfeeding educational material and individual coaching from a lactation counsellor. Group B received breastfeeding educational material with no counselling. Group C received routine antenatal care only. A total of 401 women were recruited. The results showed that women who received simple antenatal instruction with a short, single, individual counselling session combined with educational material practised exclusive and predominant breastfeeding more often than women receiving routine care alone at 3 months (OR 2.6, 95% CI 1.2 to 5.4) and 6 months (OR 2.4, 95% CI 1.0 to 5.7) postpartum. More women practised exclusive and predominant breastfeeding at 6 months among women receiving individual counselling compared with women exposed to educational material alone (OR 2.5, 95% CI 1.0 to 6.3). A number of limitations were noted for this trial. There was contamination between the groups and women in the control group came to know about the interventions offered to the other groups simply by speaking to women in those groups. There was insufficient sample size to fulfil power calculations. The most useful breastfeeding intervention includes demonstration of breastfeeding techniques (educational video), one-to-one teaching by a trained lactation counsellor, and a breastfeeding education booklet. A Canadian RCT (2006)641 sought to determine the effects of an antenatal breastfeeding workshop on maternal breastfeeding self-efficacy and breastfeeding duration. [EL = 1] One hundred and one nulliparous women expecting a single child and an uncomplicated birth, and planning to breastfeed were randomised into either the intervention group or the control group. Both groups received standard care and in addition the intervention group attended a 2.5 hour prenatal breastfeeding workshop (based on Bandura's theory of self-efficacy and adult learning principles). The main outcome measures were maternal breastfeeding self-efficacy (measured with a revised breastfeeding self-efficacy scale) and breastfeeding duration (measured at 4 weeks and 8 weeks postpartum). The study suffered from participation bias because the participants were self-selecting. Overall both the groups had higher breastfeeding rates at 8 weeks postpartum when compared with the national statistics. This suggests that owing to the participation bias the participants may have started out more committed to or more confident about breastfeeding than the general population. Higher self-efficacy scores and a higher proportion of exclusively breastfeeding women were seen in the group who attended the workshop as compared with women who did not attend the workshop, although by 8 weeks postpartum this difference was no longer statistically significant (intervention 61.7% versus control 58.9%; t = 1.60, 95% CI 6.28 to 0.70; P = 0.115). A US-based non-RCT (1997)642 examined the effect of specific antenatal breastfeeding information on postpartum rates of breastfeeding among WIC participants. [EL = 1] This information was provided in group classes by nurse practitioners. A total of 14 women in the experimental group and 17 in the control group received prenatal nutrition education through the WIC programme. The experimental group received at least one breastfeeding education class and a follow-up class was offered but not required. The control group received the standard prenatal education class which included content on the appropriate diet for pregnancy and they were taught that breastfeeding is the preferred method of infant feeding rather than the 'how-to's' of breastfeeding. All participants were interviewed at 1 month postpartum WIC visit. The study suffered from a small sample size and wide variance in the duration of breastfeeding, which led to a low statistical power. The results showed no significant difference in breastfeeding incidence between the two groups. However, there was a significantly higher percentage of women still breastfeeding at 3 and 4 months postpartum in the experimental versus the control group. The control group breastfed for 29.5 ± 43.6 days, while the experimental group breastfed for 76 days ± 104.3 (P = 0.05). It was found that multiparous women who had bottle-fed previous children breastfed for a shorter duration (18 ± 22 days) than primiparous women (60 ± 87 days) but this was not statistically significant. A US-based quasi-randomised controlled trial (1984)643 was used to determine the effect of prenatal breastfeeding education on maternal reports of success in breastfeeding and maternal perception of the infant. [EL = 1] All participants were enrolled to attend childbirth education classes and vaginally delivered full-term healthy infants without complication. Forty nulliparous women who desired to breastfeed were randomly assigned to control and experimental groups according to the childbirth class in which they were enrolled. Twenty women attended a prenatal breastfeeding education class and 20 were in the control group. The independent variable used in this study was prenatal breastfeeding education class. The two dependent variables were maternal report of success in breastfeeding and maternal perception of the infant. The maternal perception of the infant variable was measured using the Neonatal Perception Inventory (NPI). The NPI I was 40
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administered 1–2 days postpartum and the NPI II was administered at 1 month postpartum. The results showed that there was a significantly higher frequency of success in breastfeeding among primiparous women who received prenatal breastfeeding education as compared with those who did not. There was a significant difference in the NPI I scores in both experimental and control subjects at 1–2 days postpartum. The NPI II scores of the experimental mothers were significantly more positive at 1 month postpartum. Primiparous women in the experimental group reported significantly more positive NPI II scores than the control group. A quasi-experimental design with pre- and post-intervention groups was carried out in Chile (1996)644 to assess the impact of five interventions on breastfeeding patterns and duration. [EL = 2] The five interventions were: training the health team in breastfeeding; implementing activities at the prenatal clinic; implementing activities at the hospital; creating an outpatient lactation clinic; and offering the Lactational Amenorrhea Method (LAM) as an initial form of family planning. During the intervention phase, a sixth intervention (prenatal breastfeeding skills group education (PBSGE)) was added for a subset of the women in the intervention group. A subset of 59 women (for the sixth intervention) was drawn from 123 mother/child pairs of the intervention group. The women in the sixth intervention group attended the prenatal breastfeeding skills group education sessions (conducted by a trained nurse-midwife at the outpatient prenatal clinic) during the third trimester of pregnancy. Each session lasted about 20 minutes and the topics covered were breast care, breastfeeding advantages for the infant and for the mother, breastfeeding technique, anatomy and physiology of the mammary gland, prevention of breastfeeding problems, rooming-in, and immediate contact. The five interventions demonstrated a significant increase in full breastfeeding at 6 months (32% to 67%). A significantly higher percentage of the sixth intervention women were fully breastfeeding at 6 months compared with those who received only the five basic interventions (80% versus 65%). The effect was greater among nulliparous women. An Australian qualitative study (2003)645 explored the physical, social and emotional experiences influencing women's baby-feeding decisions by investigating women's own decision-making processes. [EL = 3] The study was undertaken with 29 women using face-to-face in-depth interviews that were audiotape-recorded and transcribed verbatim. Data were analysed using thematic analysis. A number of themes were identified in this study that appeared to influence the baby-feeding decision. One of the most dominant themes was the embodied expression of breastfeeding. Another dominant theme was that breastfeeding could be difficult and problematic. It was found that the women sought information from a variety of sources as well as exploring their own understandings of themselves and their breasts. Based on this knowledge the women made their antenatal baby-feeding decisions. These baby-feeding decisions grouped into four thematic groups: 'assuming I'll breastfeed'; 'definitely going to breastfeed'; 'playing it by ear'; and 'definitely going to bottle-feed'. Each of these standpoints was associated with and precipitated a number of behaviours and strategies. It was concluded that there is need for antenatal educators and midwives who provide care in pregnancy to acknowledge a range of experiences and expectations of women and to provide diverse educational opportunities to meet a range of needs. A US-based descriptive study (1982)646 sought to determine the relationship between nulliparous women's information on breastfeeding and success in breastfeeding. [EL = 3] The study hypothesis was that pregnant women having relatively more information on breastfeeding would breastfeed their infants beyond 4 weeks, as compared with pregnant women with relatively little information on breastfeeding who would breastfeed their infants for less than 4 weeks. A multiple-choice questionnaire of 26 items was developed to measure the pregnant women's knowledge about breastfeeding. The questionnaire was tested for its validity and was pilot tested on 30 nulliparous women who were not a part of the main study, which yielded a 2 week test–retest reliability of 0.87. A post-delivery mail questionnaire on breastfeeding outcome was completed 5–6 weeks following delivery and the results of the two questionnaires were correlated. The anonymity of the participants was ensured by assigning code numbers to all questionnaires. The results showed that women who breastfed beyond 4 weeks after delivery had higher overall breastfeeding information scores than mothers who breastfed less than 4 weeks. The decision to breastfeed made early in pregnancy was associated with successful breastfeeding whereas the decision to breastfeed made late in pregnancy was associated with unsuccessful breastfeeding. There was a positive correlation between breastfeeding information scores and the number of breastfeeding information sources used by nulliparous women. 41
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Evidence summary There is evidence from RCTs that breastfeeding initiation rates and, in some instances, breastfeeding duration can be improved by antenatal breastfeeding education, particularly if this is interactive and takes place in small informal groups. One-to-one counselling and peer support antenatally are also effective.
3.2.4
Nutrition-related pregnancy interventions
A Cochrane systematic review (1999)65 assessed the effects of advising pregnant women to increase their energy and protein intakes on those intakes, on gestational weight gain, and on outcome of pregnancy. [EL = 1+] The studies included made controlled comparisons of nutritional advice, whether administered on a one-to-one basis or to groups of women. The interventions included specific advice to increase dietary energy and protein intake. Dietary intake and pregnancy outcome were the main outcome measures. A total of four trials including 1108 women were included. The results showed that advice to increase energy and protein intakes seems to be successful in achieving those goals, but the increases are lower than those reported in trials of actual protein/energy supplementation. The evidence regarding the effects on pregnancy outcome are not reliable, however, as the evidence is drawn from one trial with very wide confidence intervals. None of the trials reported any potential adverse effects that might accompany increased fetal size, such as an increased risk of prolonged labour or caesarean section. It was concluded that nutritional advice appears to be effective in increasing pregnant women's energy and protein intakes, but the effects on fetal, infant or maternal outcomes remain uncertain, and seem likely to be minimal. A US-based RCT (2004)647 developed and evaluated a tailored nutrition education CD-ROM program for participants in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). [EL = 1+] Eligible participants were computer-randomised into either the intervention or the control group. The intervention group completed a baseline survey (lasting approximately 15 minutes), received the intervention programme (soap opera and interactive feedback lasting 20–25 minutes), and answered immediate postpartum questions. The control group completed the surveys but did not receive the intervention until after follow-up. Both groups were asked to return in 1 month for follow-up. At follow-up, intervention participants answered the survey questions whereas control participants completed the survey and received the tailored intervention. The study sample comprised a total of 307 respondents to the followup survey (response rate 74.8%). Ninety-six percent of participants were female, 20% were pregnant and 50% were minorities (African-American and other). The main outcome measures included total fat and fruit and vegetable intake, knowledge of low-fat and infant feeding choices, self-efficacy, and stages of change. The results showed that the intervention group members significantly increased self-efficacy and scored significantly higher on both low-fat and infant feeding knowledge compared with controls. A US-based prospective cohort study (2004)648 aimed to evaluate the efficacy of an intervention directed at preventing excessive gestational weight gain. [EL = 2+] The study used a historical control group. The intervention group constituted women with normal and overweight pregnancy BMI. The control group consisted of women with normal and overweight BMI from an earlier observational study of postpartum weight retention. One hundred and seventy-nine women in the intervention group had their gestational weight gain monitored by healthcare providers and also received postal patient education. The intervention was designed to encourage pregnant women to gain an amount of weight during pregnancy that is within the range recommended by the Institute of Medicine. It had two major components: a clinical component (that included guidance about and monitoring of gestational weight gain by healthcare providers using new tools in the obstetric charts) and a by-mail patient education programme. Three hundred and eighty-one women formed an historical control group. At 1 year postpartum, 158 women in the intervention group and 359 women in the control group were available for analysis. The study population was monitored from early pregnancy until 1 year postpartum. The results showed that low-income women who received the intervention had a significantly reduced risk of excessive gestational weight gain (OR 0.41, 95% CI 0.20 to 0.81). There was a significantly reduced risk of retaining more than 2.27 kg in low-income overweight women (OR 0.24, 95% CI 0.07 to 0.89).
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Woman-centred care and informed decision making
A Netherlands-based retrospective qualitative study (2005)649 [EL = 2] aimed to explore the use of nutrition-related information sources (mass media, social environment and health professionals) and nutrition-related information-seeking behaviours and motives before and throughout pregnancy. In-depth face-to-face interviews of 1 hour with five groups of 12 women (a total of 60 women) from various parts of the Netherlands were conducted at conference rooms or at the respondent's home and women were mainly selected via midwifery practices. The five groups included women who wanted a child, women in their first, second and third trimester of the first pregnancy and women in their first trimester of the second pregnancy. All pregnant women sought or were confronted with at least some pregnancy-specific nutrition information. Three groups of women could be distinguished in relation to the manifestation of nutrition-related informationseeking behaviours during first-time pregnancies: women who feel like a mother from the moment they know that they are pregnant; women who feel like a mother later in pregnancy; and women who do not feel like a mother yet. Each group had its own specific information-seeking behaviour. Women in the first trimester mainly sought nutrition information in the media, such as the internet, books, magazines, 9 month calendars and brochures. In the second trimester, nutrition information was sought from the 9 month calendar (fun and tips) and friends (experienced). Women in the third trimester sought information from friends (information on breastfeeding). The information sources of the second group of women were mainly brochures provided by the midwife and the midwife herself. The third group of women mainly relied on their own common sense. Secondtime pregnant women relied on their experience, the midwife and books for specific questions. A US-based retrospective study (1985)650 evaluated the effect of intensive nutrition counselling on weight gain of pregnant women and birthweight of their infants. [EL = 2] Data were collected through retrospective review of medical records. The test group consisted of 114 women who were admitted to the clinic before the 35th week of pregnancy, attended a 30 minute prenatal nutrition class given by the clinic dietician, and were counselled by the clinic dietician at each visit. This group was sampled between the years 1979 and 1981. The control group consisted of 86 women who were admitted to the prenatal clinic before 35th week of pregnancy and attended a 20 minute prenatal nutrition class, and was sampled for the years 1975 to 1977. Two different dieticians worked with the two groups. The results showed that the women in the test group gained 2.5 kg more weight than in the control group. The test group women versus control group women had fewer low birthweight infants (4% versus 13%), although this difference is not statistically significant. They also had infants weighing 100 g more at birth than infants born to women in the control group. It should be noted that women in the intervention group attended antenatal clinic significantly earlier in pregnancy than women in the control group, and had significantly more antenatal consultations. Evidence summary There is some evidence of a fair quality from the field of nutritional support that intensive antenatal dietary counselling and support is effective in increasing women's knowledge about healthy eating and can impact upon eating behaviours. There is no evidence linking this with improved pregnancy outcomes, however.
3.2.5
Smoking cessation
Findings A Cochrane systematic review (2004)651 [EL = 1+] assessed the effects of smoking cessation programmes during pregnancy on the health of the unborn baby, infant, mother and family. A total of 64 trials were included (51 RCT s with 20 931 women and six cluster-randomised trials with 7500 women). A significant reduction in smoking in the intervention groups of 48 trials was noted (RR 0.94, 95% CI 0.93 to 0.95). Smoking cessation interventions reduced low birthweight (RR 0.81, 95% CI 0.70 to 0.94) and preterm birth (RR 0.84, 95% CI 0.72 to 0.98), and there was a 33 g (95% CI 11 g to 55 g) increase in mean birthweight. The results for very low birthweight, stillbirths, and perinatal or neonatal mortality showed no statistically significant differences between groups. One intervention strategy, rewards plus social support (two trials), resulted in a significantly greater smoking reduction than other strategies (RR 0.77, 95% CI 0.72 to 0.82). Five trials of smoking relapse prevention (over 800 women) showed no statistically significant reduction in relapse.
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A UK-based prospective study (2002)652 [EL = 2+] evaluated the impact of the current antismoking advice in the UK on smoking habits of women with planned pregnancies. Two hospitals in North London were included whose policy is to provide all women at the firsttrimester booking visit with leaflets and direct counselling for women who report that they smoke. Information was collected over a 6 month period at random from women booking for routine antenatal care. The study population included 117 (65%) women who did not currently smoke (non-smokers) and 63 (35%) who were active smokers at the beginning of their pregnancy. Thirty-nine non-smokers were found to be passive smokers. Three women took up smoking during pregnancy. 84.1% of smokers made no change in their smoking behaviour during pregnancy, 11.1% reduced their cigarette consumption and only 4.8% gave up smoking during the first half of pregnancy. None of the partners changed their smoking habits. All women were aware that smoking in pregnancy could be deleterious to their health and that of their unborn baby. A US-based RCT (2006)653 [EL = 1+] tested the efficacy of a pregnancy tailored telephone counselling intervention for pregnant smokers. The intervention used a motivational interviewing style. The study hypothesised that telephone counselling would increase smoking cessation rates at the end of pregnancy and 3 months postpartum compared with a control group that was given brief counselling. Pregnant women included in the study were identified as current cigarette smokers if they had smoked at least one cigarette in the past 7 days. The study population of 442 pregnant smokers referred by prenatal providers and a managed care plan were at least 18 years of age and at up to 26 weeks of gestation. Trained counsellors using cognitive–behavioural and motivational interviewing methods called women in the intervention group throughout pregnancy and for 2 months postpartum (a mean of five calls and a mean total contact of 68 minutes). Women in the control group received just one 5 minute counselling call. The results showed that 7 day tobacco abstinence rates in the intervention versus control groups were 10.0% versus 7.5% at the end of pregnancy (OR 1.37, 95% CI 0.69 to 2.70) and 6.7% versus 7.1% at 3 months postpartum (OR 0.93, 95% CI 0.44 to 1.99). The end-of-pregnancy cessation rates increased among 201 light smokers (fewer than 10 cigarettes/day at study enrolment) in the intervention group (intervention 19.1% versus control 8.4%; OR 2.58, 95% CI 1.1 to 6.1) and among 193 smokers who attempted to quit in pregnancy before enrolment (intervention 18.1% versus control 6.8%; OR 3.02, 95% CI 1.15 to 7.94). A US-based RCT (1993)654 [EL = 1+] evaluated a brief-contact smoking cessation programme among 57 pregnant women at two urban clinics. All the women were given a specially created videotape or a booklet related to smoking. After this they were randomly assigned to receive either a nurse counselling message or usual care at the clinic. There was no statistically significant difference in smoking status between the two groups. Twelve percent reported smoking cessation at 1 month after entry in the study, 18% reported in the ninth month of pregnancy, and 9% at 1 month postpartum. Over half of the patients attempted to quit smoking in the first month and 68% made at least one quit attempt during the entire study period. A cluster RCT in New Zealand (2004)655 [EL = 1+] tested the hypothesis that in a usual primary maternity care setting appropriate interventions delivered by midwives can help women to stop or reduce smoking and facilitate longer duration of breastfeeding. The midwives were stratified by locality and randomly allocated into a control group which provided usual care and three intervention groups. In the first intervention group, a programme of education and support for smoking cessation or reduction was given. In the second one, a programme of education and support for breastfeeding was given. In the third one both programmes were given. A total of 297 women were recruited by 61 midwives. The women who received only the smoking cessation or reduction programme were significantly more likely to have reduced, stopped smoking or maintained smoking changes than women in the control group, at 28 weeks and at 36 weeks of gestation. Women who received both the smoking cessation and breastfeeding education and support programmes were significantly more likely to have changed their smoking behaviour at 36 weeks of gestation than the control group. The postnatal period showed no difference in rates of cessation or reduction between the groups. Also there was no difference in rates of full breastfeeding between the control and intervention groups for women who planned to breastfeed.
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3.2.6
Travel safety information
Findings A US-based prospective trial (1985)656 [EL = 1] administered a special 30 minute curriculum consisting of a lecture, a motion picture demonstrating the consequences of not using child car safety seats, and a question-and-answer session to couples attending prenatal classes. All parents were telephone interviewed at 4–6 months postpartum. The results showed that 96% of parents who received the special curriculum reported they used a crash-tested child car safety seat, as compared with 78% of those who had not received the curriculum. The compliance significantly rose from 60% before curriculum to 94% after curriculum at a hospital where parents were associated with low compliance (e.g. lower income, low use of seat belts, lower educational level). A prospective study (1982)657 [EL = 2] in the USA investigated the influence of an in-hospital prenatal and postpartum educational programme on the prenatal use of infant car restraints. The participants were given demonstrations and talks on automobile crash statistics in the prenatal course, and in the postpartum period a car safety film on the hospital television, a pamphlet given to each mother and instructions to nurses to encourage parents' purchase and use of car restraints. The results showed that the actual use of infant restraints on the trip home was highest in the pre- plus postnatal education group although it was not statistically significant. There was higher restraint shown in the group given counselling in any period than no counselling.
3.2.7
Alcohol
Findings Two trials were conducted in the UK (1990)658 [EL = 1+] that compared three methods of imparting basic information and advice regarding the risks of alcohol in pregnancy at the first visit to the antenatal clinic. The effects on drinking patterns were assessed by written information alone, written information coupled with personalised advice, and written information with personalised advice reinforced by a specially produced video. The written information was in the form of a special edition of the leaflet 'Pregnancy. What you need to know' published by the Health Education Council and available commonly in antenatal clinics during the 1990s. The personalised advice was given by the interviewing doctor. The 4 minute video was designed to encourage pregnant women to reduce their drinking and gave suggestions on how to do so. Trial I had Group 1 (written information) and Group 2 (written information plus verbal reinforcement) and Trial II had Group 3 (written information) and Group 4 (written information plus verbal reinforcement plus video). Three questionnaires were given to the women: the first at their first visit to the clinic, the second at about 28 weeks of gestation and the third in the week immediately prior to delivery. The results showed no significant differences within or between trials in terms of behavioural change. Significantly more women in both arms of Trial II recommended 1 unit or less a day as the safe level of drinking during pregnancy compared with women in Trial I.
3.2.8
Gestational diabetes
Findings A descriptive study with a retrospective analysis (1995)659 [EL = 2] in the USA compared two treatment approaches designed to help women with gestational diabetes manage their pregnancies: a hospital outpatient-based nursing intervention and traditional office-based care provided by obstetricians. A research model was constructed after a literature review that used three variables: input variables (risk factors prior to gestation), moderating variables (conditions that occur during pregnancy), and outcome variables (normal versus abnormal outcomes for mother and infant). The two treatment approaches were compared using this research model. In treatment 1 (nursing intervention) all patients completed the hospital gestational diabetes outpatient education programme regardless of referral source or subsequent treatments by other professionals. In treatment 2 (obstetricians only) all patients were treated by an obstetrician only (i.e. they did not participate in the nursing intervention and were not seen by an endocrinologist, a specialist in internal medicine, or a registered dietician). The study results showed that there was no statistically significant reduction in the risk of abnormal outcomes for mother or infant in either of the treatment approaches.
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Evidence summary for Sections 3.2.5 to 3.2.8 There is good-quality evidence to show that smoking cessation interventions help women reduce smoking and decrease adverse neonatal outcomes. Evidence about car travel safety is of poor quality but findings suggest focused antenatal information provision may increase appropriate use of car restraints for babies. There is a small amount of good-quality evidence on providing information about alcohol consumption in pregnancy that suggests that using a variety of methods does not alter reported behaviour, although it can improve knowledge about recommended safe levels.
3.2.9
How information is given to women antenatally
A total of nine studies (seven RCTs, one cluster controlled trial and one prospective cohort study) have been included in this section. All these studies compared different methods of providing information during the antenatal period in terms of uptake of screening tests, anxiety levels, knowledge, and other outcomes. The methodological quality of the included trials is generally good but no two studies compared similar methods of providing information. The review is further subdivided by the type of information provided, that is, general information about pregnancy/ screening tests or specific information about a disease/complication.
General information about pregnancy/screening tests (three studies)
Description of included studies A randomised trial comparing three methods of giving information for prenatal testing was conducted in the UK (1995):12 routine information given in antenatal clinics at the booking visit by the doctor or midwife (control group); extra information given individually before 16 weeks or at an extra hospital visit by a research midwife (individual group); and extra information given to a group of 4–12 women separate from the routine antenatal clinics (class group). [EL = 1+] The study population comprised pregnant women at less than 15 weeks of gestation and they were allocated to the three groups by simple randomisation using sealed opaque envelopes. The main outcome measures evaluated were attendance at the extra information sessions, uptake rates of prenatal screening tests (ultrasound, Down's syndrome, cystic fibrosis, haemoglobinopathy), levels of anxiety, understanding, and satisfaction with decisions. Questions on level of anxiety were administered at 16–18 weeks, 20 weeks, 30 weeks and 6 weeks post-delivery to assess anxiety at different times. Questions on information were administered at 16–18 weeks, and satisfaction questions at 30 and 46 weeks. All analysis was by intention-to-treat analysis but blinding was not specified and sample size calculations were not performed. A second RCT (2000)660 was conducted in five antenatal clinics in a university teaching hospital in the UK to compare the effectiveness of a touch screen method with information leaflets for providing women with information about prenatal tests. [EL = 1+] The study population comprised both low- and high-risk pregnant women at booking appointment for antenatal care. After recruitment, baseline information was collected and women were randomly allocated to the intervention (touch screen and information leaflet) or control group (leaflet only) using consecutive sealed opaque envelopes. Use of touch screen was limited to the intervention group by means of a password. The primary outcome measured was women's informed decision making on prenatal testing as measured by their uptake and understanding of the purpose of five screening tests (ultrasound scan at booking, serum screening, detailed anomaly scan, amniocentesis and chorionic villus sampling). Secondary outcomes included women's satisfaction with the information and their anxiety levels. Primary outcomes were assessed by a self-completed postal questionnaire (developed from a validated instrument) at around 16 and then 20 weeks, and anxiety by the Spielberg state-anxiety inventory. Quality control checks were conducted on a random sample of 10% of questionnaires, statistical analysis was done on an intention-to-treat basis, and power and sample size calculations were performed. A cluster RCT (2002)13 was conducted in Wales to investigate the effect of leaflets on promoting informed choice in women using maternity services. [EL = 1] Twelve maternity units each having more than 1000 deliveries annually were grouped into ten clusters (some units shared management or consultants) and randomly assigned to the intervention units (five units receiving
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set of leaflets) or control units (five units continuing with normal care) by tossing a coin. A set of ten leaflets summarising the evidence on ten decisions that women face during pregnancy and childbirth, and encouraging them to make informed decisions was used as the intervention. In the intervention units some relevant leaflets were given at 10–12 weeks and the rest at 34– 36 weeks. Participants included an antenatal sample (women reaching 28 weeks during the 6 week study period) and a postnatal sample (delivering during the study period) of women both prior to introduction of the leaflets and 9 months after they were introduced; thus four groups of participants were identified. The primary outcome measured was the change in proportion of women who reported exercising informed choice, while secondary outcomes were women's levels of knowledge, satisfaction with information, and possible consequences of informed choice. Outcomes were assessed using a postal questionnaire (piloted before use) sent at 28 weeks of gestation for the antenatal sample and 8 weeks post-delivery for the postnatal sample. Power and sample size calculations were performed, analyses were done on intention-to-treat basis and confounding variables were adjusted, but blinding of outcome investigators was not achieved. Moreover, there was selection bias (poor response rate) and the study had low power. Findings A total of 1691 women consented to participate in the UK RCT:12 567 in the control group, 563 in the individual group and 561 in the class group. The baseline demographic features of the three groups were comparable. Attendance at the extra sessions was low (overall 52%) and was lower at classes than at individual appointments (adjusted OR 0.45, 95% CI 0.35 to 0.58). Uptake of ultrasound at 18 weeks was almost universal (99%) and not affected by either intervention. Low uptake of Down's syndrome screening in the control group improved slightly after the intervention in the individual group (OR 1.45, 95% CI 1.04 to 2.02) but was not affected by extra information given in classes. High uptake of cystic fibrosis screening at the baseline was lowered both in the individual group (OR 0.44, 95% CI 0.20 to 0.97) and the class group (OR 0.39, 95% CI 0.18 to 0.86). Women in the individual group were found to have significantly reduced levels of anxiety at 20 weeks (P = 0.02) compared with the control group, and thereafter anxiety was reduced but not significantly. Pregnant women given extra information either at individual level or in classes felt that they had received more relevant information and understood it better. They were also more satisfied with the information received. In the second RCT660 of the 1050 women randomised to the intervention group (n = 524) and control group (n = 526), only 64% returned all three questionnaires and the sample sizes for measuring uptake and understanding were 358 and 376, respectively. There were no significant differences between the intervention and the control groups for the baseline characteristics and reasons or rate of loss to follow-up. More women in the intervention group underwent detailed anomaly scans compared with the control group (94% versus 87%; P = 0.01), but for the rest of the screening tests uptake rates were similar. All women in the trial had good baseline knowledge of the screening tests and this increased significantly in both the groups after the intervention, but no apparent greater gain in knowledge was seen among women in the intervention arm compared with the control arm. Levels of anxiety declined significantly among the nulliparous women in the intervention group (P 95%), and a similar proportion of women in the intervention group reported that they would recommend the touch screen to other women. The authors concluded that touch screen method conferred no additional benefit to that provided by the more traditional method of information leaflet but seemed to reduce anxiety and may be most effective for information provision to selected women, that is, those with relevant adverse history or abnormal results. In the Welsh cluster RCT13 the overall response rate was 64% with a rate of 65% (3164/4835) for the antenatal sample and 63% (3288/5235) for the postnatal one. Socio-demographic characteristics of women in the intervention and control units were similar in the antenatal sample, while in the postnatal sample respondents after the intervention were an average 7 months younger. The proportion of women who reported exercising informed choice increased slightly after the intervention in both the units, but there was no significant difference in the change between the two groups for either the antenatal or the postnatal sample. A small increase in satisfaction with information was observed in the antenatal sample of the population in the intervention units compared with the control units (OR 1.40, 95% CI 1.05 to 1.88). However, owing to operational
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difficulties, just 75% of the women in the intervention units reported receiving at least one of the information leaflets. It was concluded that evidence-based information leaflets were not effective in promoting informed choice in women using maternity services.
Specific information about Down's syndrome screening (four studies)
Description of included studies An RCT was conducted in Canada (1997)661 to investigate to what extent a newly revised educational pamphlet on triple screening (developed using consumer consultation and providers' perception and suggestions) improved patient knowledge and to identify subgroups not benefiting from these materials. [EL = 1+] The study population of women with singleton pregnancies at less than 18 weeks of gestation was recruited from six different sites in both urban and rural areas. Participants were randomly allocated (computer-generated random list in a block-randomisation sequence for each site) to receive the pamphlet on triple-marker screening in the intervention group, or a similar-appearing pamphlet on daily activities during pregnancy in the control group. The method of allocation was concealed till the time of enrolment. The primary outcome measure was the Maternal Serum Screening Knowledge Questionnaire (a validated 14-item scale). Blinding of outcome investigators was not specified. Power and sample size calculations were performed. A second RCT (2004)662 was conducted in a prenatal diagnosis clinic in the UK to evaluate decision analysis as a technique to facilitate women's decision making about prenatal diagnosis for Down's syndrome using measures of effective decision making. [EL = 1+] Pregnant women receiving a screen-positive maternal serum screening (MSS) test for Down's syndrome (risk ≥ 1 in 250) were randomly allocated to the intervention or the control group using sealed opaque envelopes. Routine consultation based on the MSS result sheet was provided to the women in the control group, while in the intervention group a decision-analysis consultation using three prompts was employed – a decision tree representing test options and consequences, a utility elicitation question prompting women to choose between the burden of having a child with Down's syndrome and that of pregnancy termination, and a threshold graph identifying the alternatives. All the consultations were audiotape-recorded, transcribed and coded. Participants also completed a questionnaire after the consultation and 1 month later after the receipt of their test results. The main outcomes measured were risk perception, test decision, subjective expected utilities, knowledge, informed decision making, conflict in decision making, anxiety, and perceived usefulness of consultation. All the consultations in the two groups were provided by a single professional and calculations for power and sample size performed. Blinding of outcome investigator and intention-to-treat analysis was carried out. Another RCT conducted in Hong Kong (2004)663 compared an interactive multimedia decision aid (IMDA) with a leaflet and a video to give information about prenatal screening for Down's syndrome, and to determine women's acceptance of IMDA. [EL = 1+] All Chinese women attending a prenatal clinic in a tertiary hospital before 20 weeks of gestation were invited to participate and offered either an integrated screening test (presenting before 15 weeks) or a serum screening test (presenting after 15 weeks). After informed consent, eligible women were randomised into the intervention group (information leaflet, 30 minute video and then browsing IMDA) or the control group (information leaflet and watching 30 minute video only) by consecutive sealed opaque envelopes. Apart from giving information contained in the leaflet and/or video, the IMDA prompted women to choose their option with information about its implication, and followed it with a frequently asked question and answer session. IMDA could only be accessed in a closed room by women in the intervention group. The primary outcome evaluated was uptake of the screening test, and secondary outcomes measured were women's initial decision, understanding, and satisfaction with the information that they received. The instrument used for measuring outcome was a questionnaire given to both the groups after watching the video, and another one given to the intervention group after the IMDA session. Analysis was done on an intention-totreat basis, and confounding variables were controlled in evaluating women's acceptance of the decision aid. Sample size was calculated prior to study. Another UK RCT (2001)664 was carried out to assess the effect of a Down's syndrome screening video (specifically produced fulfilling all RCOG recommendations) on the test uptake,
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knowledge, anxiety and worry. [EL = 1] The study population comprising consecutive pregnant women referred for antenatal care was allocated either to the intervention group (sent the video at home before the hospital booking visit) or the control group who received usual care by a quasi-randomisation technique. All women also received screening information in the form of a leaflet before booking and from a midwife at the time of booking. Outcomes evaluated were test uptake (using record linkage), knowledge (multiple-choice questionnaire with 12 items), worries (multiple-choice questionnaire with 16 items), and anxiety (Hospital Anxiety and Depression scale). Baseline characteristics of the intervention and the control group were not compared. Blinding of outcome investigator was not specified and calculations for sample size and analysis on intention-to-treat basis were not performed. Findings Findings from the Canadian RCT661 showed the success rate of the recruitment process among eligible women to be 94.7% (198/209). Baseline demographic, obstetric and medical factors were similar between the intervention/triple marker screening group (n = 133) and the control/ daily activity group (n = 65). The mean overall knowledge score was significantly higher in the intervention group (0.89 versus 0.52 on a scale from 2 to +2; P < 0.001) compared with the control group. Also women receiving pamphlet on triple screening had higher scores for the domains of test characteristics, ancillary tests and target conditions (P 0.05). After watching the video 54.1% of women in the control group and 55.1% in the intervention group reported that they had no more questions. After browsing the IMDA the proportion of women having no more questions increased to 77.0% (P < 0.001), and 86.6% of women agreed that IMDA was user-friendly and 78.9% that it was acceptable. A higher proportion of younger women (aged under 35 years) accepted IMDA compared with those over 35 years of age (P = 0.03), but the difference was not significant after adjusting for confounding variables. For the UK quasi-RCT664 a total of 993 women were allocated to the video group and 1007 to the control group. No statistically significant difference was observed in the screening uptake rate between the two groups (64.2% versus 64.7%). Questionnaires were sent at 17–19 weeks only to the first 1200 women randomised in the two groups and after exclusions the sample sizes were 499 (video group) and 552 (control group). The rate of questionnaire completion was similar between the two groups. Knowledge about screening was increased in the video group with a mean score of 7.3 compared with 6.7 in the control group (P = 0.0005), but there was no difference between the two groups in specific worries about abnormalities in the baby, or general anxiety. The outcomes were also evaluated in relation to baseline demographic characteristics of housing tenure and age. Knowledge was found to be significantly higher in owner-occupiers and older age groups, anxiety scores lower in owner-occupiers, and worry scores higher in older 49
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age groups. The authors concluded that knowledge of prenatal testing can be increased by using a video, and moreover this can be done without making women more anxious or worried about fetal abnormalities.
Specific information on preterm birth (one study)
Description of included study Patient education was included as an integral part of a multi-faceted programme aimed at reducing preterm birth deliveries in a province in New York (USA), and this cohort study (1989)665 examined specifically the effectiveness of patient education in preterm birth prevention. [EL = 2] All women beginning antenatal care by 36 weeks and not at high risk for preterm birth were enrolled for the study and offered a class about recognising the signs and symptoms of preterm labour. The class consisted of a 15 minute videotape presentation followed by a 15 minute discussion led by a registered nurse staff member where several printed educational materials were also given. Outcomes evaluated were the rates of preterm birth and low birthweight. Blinding of outcome investigators was not specified and confounding variables were not controlled. Findings The study population was 2326 women and of these 487 attended the class, with most participating between 24 and 32 weeks of gestational age. There were no significant differences between the class attendees and non-attendees for the baseline demographic and obstetric variables. Women attending classes had babies with a higher mean birthweight (P = 0.03) and gestational age (P = 0.12), but improvement in gestational age did not reach statistical significance. The preterm birth rate was reduced by 17% and low birthweight rate by 27% among women attending the classes compared with the non-attendees, but these differences were statistically not significant.
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Specific information on HIV (one study)
Description of included study This UK (Scottish) RCT (1998)666 aimed to determine whether different methods of offering voluntary HIV testing to all pregnant women would lead to significantly different uptake rates, and to assess the impact of these methods on women's satisfaction, anxiety and knowledge. [EL = 1+] All pregnant women booked in a tertiary hospital in the UK were invited to participate in the trial. Four different combinations of providing information using a leaflet sent with the booking information package ('all blood tests information' or 'HIV-specific test information') and discussion with a midwife ('minimal' or 'comprehensive') were compared. After recruitment the participants were computer-randomised into five groups: Group 1 was the control group with no leaflet or discussion; Group 2 was given 'all blood tests' leaflet and 'minimal discussion' by a midwife; Group 3 was given 'all blood tests' leaflet and 'comprehensive discussion' by a midwife; Group 4 given 'HIV-specific test' leaflet and 'minimal discussion' by a midwife; and Group 5 was given 'HIV-specific test' leaflet and 'comprehensive discussion' by a midwife. Except for Group 1, which was offered HIV testing on request, all the other four groups were directly offered the test by the midwife, that is, the policy of universal testing was followed. The key outcomes were uptake of testing and women's knowledge of HIV, satisfaction with consultation, and anxiety. Hospital records along with a questionnaire given to women after discussion with a midwife were used to assess the outcomes. Analysis was done on an intention-to-treat basis and regression used to determine independent predictors of uptake. Findings Of the 3505 women randomised at booking, 3024 participated in the study over a 10 month period. Baseline demographic characteristics of the five groups were similar. Uptake rates were 6% for the control group and each of the methods of directly offering the test resulted in a higher uptake than in the control group (χ test, df = 4, P < 0.0001). However, there was no significant difference between the four groups where the test was offered directly (χ test, df = 3, P = 0.37). The best independent predictor of uptake was being directly offered the test. General knowledge of HIV was good and did not differ significantly by the method of offering testing, but specific knowledge about HIV and benefits of testing increased with the amount of information given (χ test of linear trend, df = 4, P < 0.001). No significant difference was found regarding anxiety and satisfaction. 50
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Evidence summary for Section 3.2.9 Evidence from a single trial [EL = 1+] indicates that extra information about screening tests given individually or in a group leads to higher level of satisfaction and understanding among pregnant women. This may, in turn, decrease uptake of some screening tests. There is high-quality evidence that information leaflets are effective in increasing the knowledge of pregnant women about screening tests (general and for Down's syndrome), and the use of a touch screen method does not improve the uptake rate of screening tests compared with the leaflets. Evidence from a good-quality trial shows that decision-aid techniques are helpful to pregnant women in making informed choices about the screening tests for Down's syndrome. Results from a good-quality trial show that using an interactive multimedia decision aid does not improve the uptake of screening tests for Down's syndrome compared with the information provided by leaflets and video. There is limited evidence on effectiveness of informational material for reducing preterm deliveries. Results from a single cohort study show that educating women using a video film followed by a discussion are ineffective in preventing preterm births. Evidence from a single good-quality trial indicates that a formal offer of an HIV test accompanied by both written and verbal information leads to a higher uptake of HIV screening tests in pregnant women without increasing their anxiety compared with making the test available on request.
3.2.10
Perspectives of clinicians and women regarding information giving
Three good-quality descriptive studies have been included in this section. The first study explored and compared the perceptions of clinicians and patients regarding screening tests, the second evaluated information provided for Down's syndrome from the perspective of healthcare practitioners only, and the last one looked at the social context with respect to introduction of a new informational leaflet for prenatal care. Description of included studies A qualitative descriptive study was conducted in the USA (2005)667 to explore the interaction between the contrasting perspectives of clinicians and the patients, and consider how differences in their primary orientations might affect efforts to assure patients are making informed decisions about prenatal genetic testing. [EL = 3] This study combined data from a series of related studies and altogether a convenience sample of 40 patients and a convenience snowball sample of 50 clinicians were interviewed along with observations of 101 genetics counselling sessions. Women interviewed were those offered amniocentesis following an abnormal alpha-fetoprotein (AFP) test while the clinicians interviewed included 25 physicians, 20 clinical staff and five genetics counsellors. Patients and clinicians were interviewed from the same clinics and who had interacted with each other in order to capture their contrasting perspectives. The interviews, averaging about 2 hours, were tape-recorded and transcribed, and followed a standardised set of open-ended questions. Information and knowledge content scores were generated from the interviews based on eight informational elements considered important by the clinicians when offering amniocentesis. All phases of data processing and analysis were cross-checked during conference sessions and any discrepancy was addressed. A qualitative study in the UK (2002)668 explored the information given to pregnant women and their partners about Down's syndrome from the perspective of healthcare practitioners, and looked at some ways in which this information could be constructed. [EL = 3] Healthcare practitioners whose work was related directly or indirectly to perinatal care were recruited (n = 70) using 'snowballing' technique, and their informed consent was taken. Individual interviews lasting between 1 and 2 hours were conducted in the form of semi-structured 'guided conversations'. Most of the interviewees (56/70) then participated in group discussions with an average group size of nine (six participants, two sociologists, one group leader). Groups were of mixed disciplines and seniority and their discussions were tape-recorded, fully transcribed, analysed by content for emergent themes and then coded. Each session lasted approximately 2 hours. Findings of this study are based on the 11 group discussions that took place and do not include data from the interviews held earlier.
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Qualitative research was conducted independently but alongside the cluster-randomised trial13 to understand the social context in which the leaflets (ten pairs of informed choice) were used.14 [EL = 3] The study involved non-participant observation and in-depth interviews with health professionals and pregnant women in both the intervention (five units receiving the leaflets) and the control units (five units continuing normal care). Consultations were observed to identify how the leaflets were used and how informed choice and decision making occurred in practice. Face-to-face interviews were conducted using a semi-structured format to discuss various aspects of information giving (availability, quality and understanding), the meaning of informed choice, and the role of childbearing women in decision making. Sampling was initially 'opportunistic' depending on the availability and willingness to participate, but later became 'selective' to ensure uniform representation of both the health professionals and pregnant women. Towards the end of the intervention period, women who had questioned or declined the choices offered to them and staff who offered information withheld by their colleagues were selectively interviewed to identify the interplay between hierarchy, power and trust. Findings One-third of the women interviewed were 25–30 years of age, more than half were married and three-quarters had decided to go for amniocentesis. Almost half of the clinicians interviewed were working in private genetics specialty clinics, 22% were MD with genetics specialty and 10% were genetics counsellors. Of the 101 genetics counselling sessions, women were observed in two-thirds of cases while in the rest they were both observed and interviewed. Broadly, both the clinicians and patients shared the obvious goal of prenatal care of ensuring a healthy pregnancy, but their understanding and orientations to this undertaking were quite different. For the clinicians, consultations were a routine part of their everyday work of trying to identify, prevent and control problems. In contrast, patients considered consultations as a disruption of their routine of nurturing and protecting their pregnancy. While moving through the process of prenatal genetic diagnosis, each defined the shared goal of promoting a healthy pregnancy in strikingly different ways: Meaning of an abnormal screening test – In the genetics counselling sessions, clinicians usually began by noting that the abnormal screening test only indicates that there might be a problem (specifying a percentage 'risk') and explaining that further testing was required for the diagnosis. Most of the patients (87%) felt anxious with the news and many began crying, while 63% said that they were told nothing about the reason for referral to a genetics specialist and they thought it was a routine prenatal visit. Ultrasound to confirm dates – For the clinicians, it was a mundane step to verify whether further testing was required and usually occurred without discussion with the patient. The patient on the other hand was primarily concerned with getting information about the wellbeing of the baby. Offer of amniocentesis – Clinicians were primarily concerned with finding and responding to a problem and 96% described acceptance of testing by the patients as being based on their desire to know the wellbeing of the baby. All the patients accepting the offer of amniocentesis said they had wanted reassurance about the baby's health after the positive screening tests results, while 90% of women declining the offer did it for not willing to risk a miscarriage. Clinicians discussed all the essential elements of information giving in only 59% of the consultations. Elements most consistently covered were that the test is optional, the risks of the procedure, and the risks for the anomaly, while the least covered elements were the nature of the anomaly and alternatives to amniocentesis. Patients' overall knowledge score averaged about 53% and the elements for which they showed most complete knowledge included reasons for doing amniocentesis, that the test is optional, the nature of the invasive procedure, and what information this test could give. The elements least completely discussed included risk of anomaly, alternatives to amniocentesis and nature of the anomaly. However, there was no statistical correlation between the completeness of information included in consultants' consultations and the level of knowledge exhibited by the patients during the interviews (Pearson correlation = 0.204; P = 0.289).
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In the UK qualitative study668 of the 56 health practitioners who participated in the group discussions there were 20 midwives, 20 doctors, and 16 from a variety of other disciplines. The principal findings from the study were as follows: What women were thought to know about Down's syndrome – Practitioners felt that more time was spent explaining the complexities of the actual screening process rather than the condition being screened. Moreover, many women did not have adequate knowledge about some of the basic features of Down's syndrome. This was ascribed to fewer births of infants with Down's syndrome and medical innovations shifting people's perception of normality. How information about Down's syndrome is presented – Although many practitioners felt that their way of providing information influenced decision making by pregnant women, they seldom made any positive and realistic statement about the condition. Leaflets distributed to the pregnant women at the time of booking visit were frequently used to provide information. These leaflets contained little information about Down's syndrome itself and devoted most of its space to the screening process. Many staff members were also reluctant to provide positive aspects of information as they felt that it might