A comparison of oral misoprostol with vaginal misoprostol administration in second-trimester pregnancy termination for fetal abnormality
Obstetrics and Gynecology
OBJECTIVE: To compare the clinical efficacy and side effects of oral misoprostol with vaginal misoprostol for secondtrimester pregnancy termination. METHODS: A randomized clinical trial of medical pregnancy termination between 14 and 26 weeks' gestation was conducted. Three misoprostol regimens were compared: 400 g vaginally at 6-hour intervals (group 1), 400 g orally at 3-hour intervals (group 2), and a loading dose of 600 g vaginally followed by 200 g orally at 3-hour intervals (group 3). A
... vals (group 3). A sample size of 225 women was required for equivalence of the three regimens, with an interim safety analysis planned at 80 women. RESULTS: A significant difference between the groups was evident at the interim safety analysis and the study ceased. The subset of 84 women recruited before the study closure is described. There was a significant difference in the median time to achieve delivery among the three groups: group 1, 14.5 hours (95% confidence interval 12.0, 16.9), versus group 2, 25.5 hours (13.5, 23.8), versus group 3, 16.4 hours (interquartile range 14.2-37.3) (P ؍ .042). Within 24 hours of commencement 85.7% of women in group 1, 44.8% in group 2, and 74.1% in group 3 delivered (P ؍ .003). At 48 hours 0% in group 1, 20.7% in group 2, and 3.7% in group 3 were undelivered (P ؍ .011). There was no difference in women's perceptions of the termination process.