Extemporaneous Preparation of Misoprostol Gel for Cervical Ripening: A Randomized Trial

Abstract

Objective: To compare the safety and efficacy of intravaginal misoprostol gel with that of tablets for ripening the cervix and inducing labor in women with unfavorable cervices.Methods: Four hundred sixty-seven gravidas were randomized to receive misoprostol tablets (n = 234) or misoprostol gel (n = 233). The gel was prepared in the antepartum unit immediately before use by dissolving the tablet in 1 mL normal saline and mixing with 4 mL hydroxyethylcellulose gel. In both groups, a 50-μg dose was applied intravaginally every 8 hours for two doses, then increased to 100-μg for a total of six applications or 500 μg.Results: The mean interval in hours from drug administration to start induction or labor (13.8 versus 18.2) and delivery (22.4 versus 29.0) was significantly less in the tablet group than in the gel group (P < .01 for both). Oxytocin and epidural use and the mean number of misoprostol insertions (1.4 versus 1.9) were lower in the tablet group than in the gel group (P < .05 for all). The incidences of tachysystole (13.7 versus 7.3%) and hyperstimulation (15.8 versus 7.7%) were significantly higher in the tablet group than in the gel group. Cesarean delivery rates and neonatal outcomes were similar between the groups.Conclusion: Intravaginal misoprostol gel is associated with fewer uterine contractile abnormalities than the tablet form of the drug but results in a slower time to labor or delivery.