A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion

Abstract

Background: An 800-mcg dose of buccal misoprostol following mifepristone has been shown to be highly effective in terminating pregnancies through 63 days since the last menstrual period (LMP) (B. Winikoff, I.G. Dzuba, M.D. Creinin, et al., Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol 2008; 112: 1303-1310). However, a two 200-mcg misoprostol pill option would simplify administration, and potentially reduce costs and increase women's satisfaction. This study compares a 400-mcg dose (Group I) to an 800-mcg dose (Group II) of buccal misoprostol.

Study design: Eligible and consenting women requesting medical termination of early pregnancy (n=1122) were randomized and instructed to take misoprostol 36 to 48 h after taking 200 mg mifepristone. Follow-up visits occurred 12 to 15 days after mifepristone administration.

Results: Ninety-six percent of women in both groups had successful abortions. Women in Group I experienced significantly less vomiting and fever/chills than women in Group II. Ninety-six percent of women in both groups found the procedure very satisfactory or satisfactory.

Conclusions: Four hundred micrograms of buccal misoprostol is as effective as the standard 800-mcg dose in terminating pregnancies up to 63 days LMP and reduces side effects.