Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

• Published in: The Lancet (British edition) 2020-09, Vol.396 (10253), p.770-778
• Main Authors: Chu, Justin J, Devall, Adam J, Beeson, Leanne E, Hardy, Pollyanna, Cheed, Versha, Sun, Yongzhong, Roberts, Tracy E, Ogwulu, C Okeke, Williams, Eleanor, Jones, Laura L, La Fontaine Papadopoulos, Jenny H, Bender-Atik, Ruth, Brewin, Jane, Hinshaw, Kim, Choudhary, Meenakshi, Ahmed, Amna, Naftalin, Joel, Nunes, Natalie, Oliver, Abigail, Izzat, Feras, Bhatia, Kalsang, Hassan, Ismail, Jeve, Yadava, Hamilton, Judith, Deb, Shilpa, Bottomley, Cecilia, Ross, Jackie, Watkins, Linda, Underwood, Martyn, Cheong, Ying, Kumar, Chitra S, Gupta, Pratima, Small, Rachel, Pringle, Stewart, Hodge, Frances, Shahid, Anupama, Gallos, Ioannis D, Horne, Andrew W, Quenby, Siobhan, Coomarasamy, Arri
• Format: Article
• Language: English
• Subjects: Abortion, Missed - drug therapy; Adult; Analysis; Bleeding; Clinical trials; Double-Blind Method; Double-blind studies; Drug Therapy, Combination; Gestational age; Health services; Hospitals; Humans; Informed consent; Management; Mifepristone; Mifepristone - therapeutic use; Miscarriage; Misoprostol; Misoprostol - therapeutic use; Oxytocics - therapeutic use; Pharmacists; Pregnancy; Progesterone; R&D; Randomization; Research & development; Surgery; Technology assessment; Treatment Outcome; Ultrasonic imaging; Ultrasound; Uterus; Vagina; Womens health
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(20)31788-8

The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (