Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days

The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, ie, 200 mg, and vaginal misoprostol 800 mu g to induce abortion in subjects less than or equal to 56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women greater than or equal to 18 years, less than or equal to 63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 mu g vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the less than or equal to 56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects less than or equal to 56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the less than or equal to 56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects less than or equal to 56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the less than or equal to 56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall Procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 mu g at 48 h were highly effective and acceptable to women less than or equal to 63 days pregnant, thereby expanding the number of women who call access a medical abortion. CONTRACEPTION 2000;61:41-46 (C) 2000 Elsevier Science inc. All rights reserved.