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Mifepristone pretreatment improves success rate of misoprostol for early pregnancy loss
Clinical Question
In women with an early pregnancy loss, does pretreatment with mifepristone before misoprostol improve outcomes over treatment with misoprostol alone?
Bottom line
In women with an early pregnancy loss between 5 weeks' and 12 weeks' gestation, pretreatment with 200 mcg oral mifepristone before 800 mcg vaginal misoprostol increases the likelihood of successful expulsion of the gestational sac (number needed to treat [NNT] = 6). 1b-
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Government
Setting: Outpatient (any)
Synopsis
The researchers recruited adult women who had a closed cervical os and an ultrasound that showed a nonviable intrauterine pregnancy between 5 weeks' and 12 weeks' gestation. They excluded women with an open cervical os or no visible gestational sac, anemia, a viable or ectopic pregnancy, or any contraindication to the study medications. The mean age of the 300 participants was 30 years, 44% were black, most had a 6- to 8-week gestation. Women were randomized to receive directly observed therapy with oral mifepristone 200 mcg followed by 800 mcg misoprostol (4 tablets) inserted vaginally 24 hours later, or to the misoprotol alone. Although women and their physicians were not masked to the treatment assigned, the person assessing the ultrasound was masked. Each woman had a follow-up visit at 1 day to 4 days, and if a gestational sac was present on ultrasound, she was offered a second dose of misoprostol or the option of surgical evacuation, with follow up approximately 1 week after that. All women had a final follow-up visit at 1 month. Only 7 women were lost to follow up or withdrew consent in each group. The likelihood of expulsion at the initial follow-up visit was significantly higher with the combination therapy (84% vs 67%; 95% CI for the difference 7% to 26%; NNT = 6). Women who did not follow instructions and took the misoprostol fewer than 18 hours after the mifepristone had a somewhat lower likelihood of success (80% vs 87%; P = .22). Among women who had up to 2 doses of misoprostol, gestational sac expulsion at 30 days was also significantly more likely in the combination therapy group (91% vs 76%; NNT = 7). Women receiving pretreatment with mifepristone were significantly more likely to experience vomiting (27% vs 15%; number needed to treat to harm [NNTH] = 8) and headache (59% vs 48%; NNTH = 9).
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
good poem
Interesting. But makes pathophysiological sense, completely. Good information to provide insight to women who might ask for added insight from a family doc.