One hundred twenty women were enrolled into three equal groups by gestational age: ≤49 days (Group 1), 50–56 days (Group 2) and 57–63 days (Group 3). After swallowing 200 mg of mifepristone, subjects received 800 mcg buccal misoprostol. Participants returned in 24±1 h for evaluation of expulsion by ultrasonography. Women with a persistent gestational sac received 800 mcg vaginal misoprostol. Further follow-up occurred at 1, 2 and 5 weeks by telephone or in person, as appropriate. Sample sizes for each group were estimated with the aim of establishing a 24-h expulsion rate of 90 % (95 % CI=76–95).
The 24-h expulsion rates for Groups 1, 2 and 3 were 73 % (95 % CI=56–85), 69 % (95 % CI=52–83) and 73 % (95 % CI=56–85), respectively. Common side effects were nausea (62 % ), vomiting (33 % ) and diarrhea (48 % ), which did not differ by gestational age. Forty-three percent of subjects found the taste of buccal misoprostol objectionable; 30 % found buccal retention uncomfortable or inconvenient, and 10 % reported oral irritation, sensitivity, numbness or oral ulcers.
Simultaneous oral mifepristone and buccal misoprostol had a lower-than-hypothesized expulsion rate at 24 h. Although overall success rates at 7 or 15 days could have been higher than those observed at 24 h, we believe that this regimen does not warrant further study.