Mifepristone, misoprostol combo effectively manages missed miscarriage: MifeMiso trial
Birmingham, UK: Mifepristone plus misoprostol is more effective than misoprostol alone for the treatment of missed miscarriage, suggests a recent study in the journal Lancet. According to the study, offering mifepristone pretreatment before misoprostol to women with missed miscarriage increases the chance of successful miscarriage management, and also it reduces the requirement for miscarriage surgery.
A missed miscarriage (also known as silent or delayed miscarriage ) occurs when the fetus is no longer viable but the body does not identify the pregnancy loss and is identified on an ultrasound scan during the first 14 weeks of gestation. In this miscarriage, women do not generally experience miscarriage symptoms. Pregnancy tissue is retained in the uterus in a missed miscarriage whereas in incomplete miscarriage pregnancy tissue gets partly expelled by the uterus.
The prostaglandin misoprostol and anti-progesterone drug mifepristone can be used for missed miscarriage treatment. However, it is not clear whether a combo of misoprostol and mifepristone is more effective than the administration of misoprostol alone.
Justin J Chu, University of Birmingham, Birmingham, UK, and colleagues investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
MifeMiso is a double-blind, multicenter and placebo-controlled, randomized trial conducted across 28 UK hospitals. Eligibility criteria -- Age; 16 years and above, 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. 2595 women met the eligibility criteria for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women).
The primary outcome was a failure to spontaneously pass the gestational sac within 7 days after random assignment.
Key findings of the study include:
- 696 (98%) of 711 women had available data for the primary outcome.
- 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73).
- 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71).
- There was no difference in incidence of adverse events between the study groups.
"Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery," concluded the authors.
The study, "Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial," is published in the journal Lancet.