Background: There have been no US studies published on the effectiveness, safety, time to bleeding, and acceptability of misoprostol administered by vagina at home and repeated, if needed, after mifepristone was administered for abortion in women up to 8 weeks pregnant.
Methods: A prospective trial was conducted with women up to 8 weeks pregnant wanting an abortion. After receiving mifepristone 600 mg orally, subjects self-administered vaginal misoprostol 800 micrograms at home 2 days later. Subjects returned within 7 days, and if the gestational sac was still present on ultrasound, a repeat dose of misoprostol was administered in the office. Subjects completed a daily symptom log and a questionnaire on the acceptability of the procedures.
Results: Of the 166 subjects, 163 (98%) had a complete medical abortion. Three subjects presented with persistent bleeding and an incomplete abortion from 27 to 35 days after taking mifepristone and required surgical intervention. Vaginal spotting or bleeding occurred in 104 (62%) subjects before taking misoprostol, and 18 (11%) did not use misoprostol. Bleeding occurred on average 3.5 hours (SD, 3.2) after taking misoprostol. Six (4%) subjects required a second dose of misoprostol. Gastrointestinal side effects were common, mild, and brief. One hundred fifty-nine (96%) subjects agreed that the procedure went well, and 146 (90%) agreed that home administration of misoprostol was acceptable.
Conclusions: Two days after taking mifepristone, misoprostol administered by vagina was found to be safe, highly effective, and acceptable to women. Since only 6 subjects needed a second dose of misoprostol, conclusions about repeat doses are not possible. This procedure is a promising alternative to surgical abortion.