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King’s Research Portal DOI: 10.1002/14651858.CD007223.pub4 Document Version Publisher's PDF, also known as Version of record Link to publication record in King's Research Portal Citation for published version (APA): Kim, C., Barnard, S., Neilson, J. P., Hickey, M., Vazquez, J. C., & Dou, L. (2017). Medical treatments for incomplete miscarriage. Cochrane Database of Systematic Reviews, 2017(1), [CD007223]. https://doi.org/10.1002/14651858.CD007223.pub4 Citing this paper Please note that where the full-text provided on King's Research Portal is the Author Accepted Manuscript or Post-Print version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version for pagination, volume/issue, and date of publication details. And where the final published version is provided on the Research Portal, if citing you are again advised to check the publisher's website for any subsequent corrections. 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Sep. 2021 Cochrane Database of Systematic Reviews Medical treatments for incomplete miscarriage (Review) Kim C, Barnard S, Neilson JP, Hickey M, Vazquez JC, Dou L Kim C, Barnard S, Neilson JP, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD007223. DOI: 10.1002/14651858.CD007223.pub4. www.cochranelibrary.com Medical treatments for incomplete miscarriage (Review) Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 6 OBJECTIVES ..................................... 7 METHODS ...................................... 7 RESULTS....................................... 11 Figure1. ..................................... 13 Figure2. ..................................... 17 Figure3. ..................................... 18 Figure4. ..................................... 19 Figure5. ..................................... 20 Figure6. ..................................... 21 ADDITIONALSUMMARYOFFINDINGS . 36 DISCUSSION ..................................... 40 AUTHORS’CONCLUSIONS . 41 ACKNOWLEDGEMENTS . 42 REFERENCES ..................................... 42 CHARACTERISTICSOFSTUDIES . 55 DATAANDANALYSES. 101 WHAT’SNEW..................................... 111 HISTORY....................................... 111 CONTRIBUTIONSOFAUTHORS . 112 DECLARATIONSOFINTEREST . 112 SOURCESOFSUPPORT . 112 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 112 INDEXTERMS .................................... 112 Medical treatments for incomplete miscarriage (Review) i Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Medical treatments for incomplete miscarriage Caron Kim1, Sharmani Barnard2, James P Neilson3, Martha Hickey4, Juan C Vazquez5, Lixia Dou6 1Department of Reproductive Health and Research, WHO, Geneva, Switzerland. 2Centre for Global Health, Kings College London, London, UK. 3The University of Liverpool, Liverpool, UK. 4The University of Melbourne, The Royal Women’s Hospital, Melbourne, Australia. 5Departamento de Salud Reproductiva, Instituto Nacional de Endocrinologia (INEN), Habana, Cuba. 6Cochrane Pregnancy and Childbirth Group, Department of Women’s and Children’s Health, The University of Liverpool, Liverpool, UK Contact address: Caron Kim, Department of Reproductive Health and Research, WHO, 20 Avenue Appia, Geneva, 1211, Switzerland. kimca@who.int. Editorial group: Cochrane Pregnancy and Childbirth Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 1, 2017. Citation: Kim C, Barnard S, Neilson JP, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD007223. DOI: 10.1002/14651858.CD007223.pub4. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus (’evacuation of uterus’). However, medical treatments, or expectant care (no treatment), may also be effective, safe, and acceptable. Objectives To assess the effectiveness, safety, and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks). Search methods We searched Cochrane Pregnancy and Childbirth’s Trials Register (13 May 2016) and reference lists of retrieved papers. Selection criteria We included randomised controlled trials comparing medical treatment with expectant care or surgery, or alternative methods of medical treatment. We excluded quasi-randomised trials. Data collection and analysis Two review authors independently assessed the studies for inclusion, assessed risk of bias, and carried out data extraction. Data entry was checked. We assessed the quality of the evidence using the GRADE approach. Main results We included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks’ gestation. Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on ’deaths or serious complications’. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). Medical treatments for incomplete miscarriage (Review) 1 Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Sixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on ’deaths or serious complications’. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women’s satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence). Five trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches. Authors’ conclusions The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long- term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks’ gestation. PLAIN LANGUAGE SUMMARY Medical treatments for incomplete miscarriage What is the issue? Miscarriage is when a pregnant woman loses her baby before the baby would be considered able to survive outside the womb, i.e. before 24 weeks’ gestation. Miscarriage occurs in about 10% to 15% of pregnancies and the signs are