Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage
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Ectopic pregnancy and miscarriage: Diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage National Collaborating Centre for Women’s and Children’s Health Ectopic pregnancy and miscarriage: Diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage National Collaborating Centre for Women’s and Children’s Health Commissioned by the National Institute for Health and Clinical Excellence December 2012 Published by the RCOG 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 2012 © 2012 National Collaborating Centre for Women’s and Children’s Health 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. This guideline has been fully funded by NICE. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient. Implementation of this guidance is the responsibility of local commissioners and/or providers. ii Contents Contents iii 1 Guideline summary 1 1.1 Guideline development group membership, NCC-WCH staff and acknowledgements 1 1.2 Care pathway 2 1.3 Key priorities for implementation 10 1.4 Recommendations 12 1.5 Key research recommendations 22 1.6 Research recommendations 25 1.7 Schedule for updating the guideline 26 2 Introduction 27 2.1 Early pregnancy complications 27 2.2 For whom is this guideline intended 28 2.3 Related NICE guidance 28 3 Guideline development methodology 29 3.1 Introduction 29 3.2 Developing review questions and protocols and identifying evidence 29 3.3 Reviewing and synthesising evidence 30 3.4 Emotional support 31 3.5 Incorporating health economics 31 3.6 Evidence to recommendations 32 3.7 Stakeholder involvement 33 4 Emotional support and information giving 34 4.1 Introduction 34 4.2 Psychological and emotional support 34 5 Early pregnancy assessment units 47 5.1 Introduction 47 5.2 Clinical and cost effectiveness of early pregnancy assessment units 47 5.3 Model for service organisation and delivery of EPAUs 51 6 Diagnosis of ectopic pregnancy and miscarriage 68 6.1 Signs and symptoms of ectopic pregnancy 68 6.2 Ultrasound for determining a viable intrauterine pregnancy 77 6.3 Accuracy of imaging techniques for diagnosis of an ectopic pregnancy 82 6.4 Diagnostic accuracy of two or more human chorionic gonadotrophin (hCG) measurements for ectopic pregnancy 88 6.5 Diagnostic accuracy of two or more hCG measurements plus progesterone for ectopic pregnancy 93 6.6 Diagnostic accuracy of two or more hCG measurements for viable intrauterine pregnancy 95 6.7 Diagnostic accuracy of two or more hCG measurements plus progesterone for viable intrauterine pregnancy 98 7 Management of threatened miscarriage and miscarriage 103 7.1 Introduction 103 7.2 Progesterone for threatened miscarriage 103 7.3 Expectant management compared with active treatment of miscarriage 111 7.4 Surgical management compared with medical management of miscarriage 122 7.5 Misoprostol and mifepristone for managing miscarriage 135 7.6 Setting for surgical management of miscarriage 176 iii Ectopic pregnancy and miscarriage 8 Management of ectopic pregnancy 182 8.1 Introduction 182 8.2 Surgical compared with medical management of ectopic pregnancy 182 8.3 Laparotomy compared with laparoscopy for ectopic pregnancy 194 8.4 Salpingectomy compared with salpingotomy for ectopic pregnancy 204 9 Anti-D rhesus prophylaxis 213 9.1 Introduction 213 9.2 Anti-D rhesus prophylaxis for threatened miscarriage, miscarriage and ectopic pregnancy 213 9.3 Anti-D rhesus prophylaxis – dose 217 10 Health economics 222 10.1 Introduction 222 10.2 Progesterone for threatened miscarriage 222 10.3 Management of miscarriage 231 10.4 Management of ectopic pregnancy 236 11 References 264 12 Abbreviations and glossary 278 12.1 Abbreviations 278 12.2 Glossary 280 iv 1 Guideline summary 1.1 Guideline development group membership, NCC- WCH staff and acknowledgements GDG members Mary Ann Lumsden Professor of Gynaecology and Medical Education (Chair) Fiona Blake Consultant psychiatrist Nicola Davies General practitioner Karen Easton Consultant nurse Roy Farquharson Consultant obstetrician and gynaecologist Joanne Fletcher Consultant nurse Liz Jones Lay member (stood down July 2011) Julie Orford Lay member (joined July 2011) Caroline Overton Consultant obstetrician and gynaecologist Shammi Ramlakhan Consultant in emergency medicine Helen Wilkinson Lay member National Collaborating Centre for Women’s and Children’s Health (NCC-WCH) Lauren Bardisa-Ezcurra Research fellow (until April 2011) Zosia Beckles Information scientist Liz Bickerdike Research assistant (from April 2012) Rupert Franklin Project manager Maryam Gholitabar Research associate Paul Jacklin Senior health economist David James Clinical co-director (women’s health) Emma Newbatt Research associate Roz Ullman Senior research fellow and clinical lead (midwifery) External advisers Janette Keit Consultant sonographer David Roberts Professor of haematology Acknowledgements Additional support was received from: Wahab Bello, Julie Hodge Allen, Juliet Kenny, Edmund Peston and Wendy Riches at the NCC-WCH 1 Ectopic pregnancy and miscarriage 1.2 Care pathway A. Providing women with information and emotional support Treat all women with early pregnancy complications with dignity and respect. Be aware that women will react to complications or the loss of a pregnancy in different ways. Provide all women with information and support in a sensitive manner, taking into account their individual circumstances and emotional response. (For further guidance about providing information, see Patient experience in adult NHS services [NICE clinical guidance 138, 2012]). Healthcare professionals providing care for women with early pregnancy complications in any setting should be aware that early pregnancy complications can cause significant distress for some women and their partners. Healthcare professionals providing care for these women should be given training in how to communicate sensitively and breaking bad news. Non-clinical staff such as receptionists working in settings where early pregnancy care is provided should also be given training on how to communicate sensi tively with women who experience early pregnancy complications. Throughout a woman’s care, give her and (with agreement) her partner specific, evidence-based information in a variety of formats. This should include (as appropriate): • When and how to seek help if existing symptoms worsen or new symptoms develop, including a 24-hour contact telephone number. • What to expect during the time she is waiting for an ultrasound scan. • What to expect during the course of her care (including expectant management), such as the potential length and extent of pain and/or bleeding, and possible side effects. This information should be tailored to the care she receives. • Information about the likely impact of her treatment on future fertility. • Information about post-operative care (for women undergoing surgery). • What to expect during the recovery period – for example, when it is possible to resume sexual activity and/or try to conceive again, and what to do if she becomes pregnant again. This information should be tailored to the care she receives. • Where to access support and counselling services, including leaflets, web addresses and helpline numbers for support organisations. Ensure that sufficient time is available to discuss these issues with women during the course of their care and arrange an additional appointment if more time is needed. After an early pregnancy loss, offer the woman the option of a follow-up appointment with a healthcare professional of her choice. Throughout the care pathway, where these symbols appear, refer back to section A and provide women with information about: ! Where to seek help in an Where to access support The recovery period emergency and counselling services 2 Guideline summary B. Initial clinical assessment Refer women who are Women with pain and/or bleeding, or haemodynamically unstable, or in atypical symptoms suggestive of whom there is significant concern early pregnancy problems [see about the degree of pain or recommendation 11]