A randomized clinical trial comparing the short-term side effects of sublingual and buccal routes of misoprostol administration for medical abortions up to 63 days' gestation.

Background: Buccal misoprostol 800 mcg and sublingual misoprostol 800 mcg show high efficacy when used with 200 mg mifepristone for early pregnancy termination but have different side effect profiles. This is the first double-blind randomized trial comparing the side effect profiles of these two routes of administration of misoprostol when used with mifepristone for termination of pregnancies up to 63 days' gestation.

Study Design: Eligible women (n=90) who requested legal termination of pregnancy up to 63 days' gestation were randomized to two groups and given 200 mg of oral mifepristone followed 48 h later by 800 mcg of either sublingual (n=45) or buccal (n=45) misoprostol.

Results: Most of the side effects including fever were more common in the sublingual group, but only the incidence of chills was significantly higher in the sublingual group (55.6% vs 91.1%, p=.0001). Complete abortion occurred in 95.4% [95% confidence interval (CI): 84.9-99.5] of women in the buccal group and 97.8% (95% CI: 88.2-99.9) in the sublingual group.

Conclusions: When combined with mifepristone for termination of pregnancy up to 63 days, both the buccal and sublingual routes are effective routes of administration. The sublingual route tended to be associated with more side effects.