Comparison of misoprostol‐only and combined mifepristone–misoprostol regimens for home‐based early medical abortion in Tunisia and Vietnam

Abstract Objective To assess the potential advantages of combined mifepristone–misoprostol versus misoprostol‐only for early medical abortion. Methods A double‐blind randomized placebo controlled study was conducted that enrolled 441 pregnant women (< 63 days since last menstrual period) at 2 hospitals in Tunisia and Vietnam. The mifepristone–misoprostol group (n = 220) received 200 mg of mifepristone on day 1 and 800 μg buccal misoprostol followed by placebo 3 hours later on day 2. The misoprostol‐only group (n = 221) received placebo on day 1 and 1600 μg of misoprostol (2 doses of 800 μg, given 3 hours apart) on day 2. All medications were self‐administered at home with follow‐up 1 week later. The primary outcome was complete uterine evacuation without surgical intervention. Results Successful uterine evacuation occurred for 78.0% (n = 170) of women with misoprostol only versus 92.9% (n = 195) of women with mifepristone–misoprostol (relative risk 0.84, 95% CI, 0.78–0.91; P < 0.001). Ongoing pregnancy occurred for 13.8% (n = 30) of women given misoprostol‐only and 1.4% (n = 3) of women given mifepristone–misoprostol (relative risk 9.63, 95% CI 2.98–31.09; P < 0.001). Conclusion Mifepristone plus misoprostol is significantly more effective than misoprostol‐only for early medical abortion. Clinical trials.gov registration number: NCT00680394 .