OBJECTIVE: To estimate the effect of outpatient administration of a single d os e of vaginal misoprostol at term on the interval to delivery in women with unfav orable cervices. METHODS: Randomized, double blind, placebo-controlled trial co mparing a single 25-μg outpatient intravaginal dose of misoprostol to placebo in pregnant women with Bishop scores less than 9 at 40 weeks or greater. After p lacement of the study medication, subjects were permitted to go into spontaneous labor unless an indication for induction developed. Analysis was by intent to t reat. The interval to delivery, defined as the time from medication placement to delivery, was compared by Student t test and by survival analysis with the log -rank test. RESULTS: Thirty-three women were randomly assigned to receive miso prostol, and 35 were assigned to receive placebo. The mean interval to delivery was significantly less in the misoprostol group, 4.2 ±.4.1 compared with 6.1 ± .3.6 days, P = .04. The interval to delivery for only the nulliparous patients w as significantly less in the misoprostol group, 4.2 ±.4.0 compared with 7.2 ±. 3.7 days, P = .02. The survival curves for the interval to delivery were signifi cantly different (P = .04 by log-rank test) with 4.1 days median interval to de livery for misoprostol compared with 9.2 days for placebo. There were no adverse outcomes in either group. CONCLUSION: A single 25-μg outpatient intravaginal dose of misoprostol is effective in decreasing the interval to delivery in women with unfavorable cervices at term.
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