A prospective open-label study of home use of mifepristone for medical abortion in Nepal.

OBJECTIVE: To assess the uptake and acceptability of self-administration of mifepristone at home for medical abortion in Nepal. METHODS: A prospective, comparative, non-randomized, open-label study was conducted at two hospitals in Kathmandu, Nepal, between November 11, 2009, and January 15, 2011. All women in good health and aged 18 years or older who sought medical abortion after fewer than 64 days of pregnancy were enrolled. Participants were offered the choice of taking 200mg mifepristone orally in the clinic or at home; all participants self-administered 400 µg of sublingual misoprostol at home 24-72 hours later. All participants were scheduled to return to the clinic within 14 days of mifepristone administration for follow-up. RESULTS: Among 200 participants, 144 (72.0%) opted to take the mifepristone at home. Medical abortion was successful in 130 (95.6%) of 136 women in the home group who were followed up and 53 (94.6%) of 56 women in the clinic group. Only 4 (2.9%) women in the home group took the mifepristone after the scheduled time. Overall, 133 (97.8%) women in the home group stated that they would recommend home administration of mifepristone if a friend wanted a medical abortion. CONCLUSION: Self-administration of mifepristone outside the clinic should be offered to all women as part of routine medical abortion services in Nepal. Clinical trials.gov: NCT00994734.

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

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 200mg 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.