Vaginally administered misoprostol for outpatient cervical ripening in pregnancies complicated by diabetes mellitus

Objective: To compare the use of vaginally administered misoprostol to placebo for outpatient labor induction in patients with diabetes. Study Design: In this double-masked, controlled clinical trial, pregnant women with diabetes and gestational age of >38 weeks were randomized to receive 25 μg misoprostol or placebo vaginally on days 1 and 4 of a 7-day outpatient cervical ripening period. If necessary, inpatient labor induction was managed by using a standard protocol. Results: Of 120 women included in the study, 57 received misoprostol and 63 received placebo. Most of the women had been diagnosed with gestational (Class A) diabetes. Similar numbers of misoprostol and placebo-treated women delivered within 7 days of the first dose (31/57 [54%] vs 36/63 [57%], P = .63). The mean (±SEM) interval from induction to delivery was similar (8530.5 minutes ±1439.7 minutes vs 6712.5 minutes ±606.4 minutes, P = .23). Conclusion: Vaginally administered misoprostol was no more effective than placebo in reducing the need for inpatient labor induction or the induction-delivery interval. Outpatient cervical ripening with use of vaginally administered misoprostol was well tolerated. (Am J Obstet Gynecol 2001;185:916-9.)