A randomized clinical trial comparing misoprostol with prostaglandin E-2 gel for preinduction cervical ripening

OBJECTIVE: Our purpose was to perform a randomized trial comparing intravaginal misoprostol to intravaginal prostaglandin E-2 gel for preinduction cervical ripening evaluating efficacy and side effects. STUDY DESIGN: Seventy-five women seen for induction of labor were randomized to receive 100 mu g of intravaginal misoprostol or 5 mg of pharmacy-prepared intravaginal prostaglandin E-2 gel for cervical ripening before oxytocin induction. Six hours after placement of the study agent, patients were given oxytocin if they were not in labor. The primary outcome measure was induction-to-delivery time; secondary measures were change in Bishop score, delivery mode, and side effects. Results were analyzed by the Student t test and Fisher's exact test, with p < 0.05 considered significant. RESULTS: There was no difference in the incidence of primiparity or the median initial Bishop score between the two study groups. The mean time to delivery and the need for oxytocin was significantly less for subjects receiving misoprostol. There was no difference in the incidence of uterine hyperstimulation syndrome or cesarean delivery between the groups. CONCLUSIONS: This randomized clinical trial indicates that misoprostol is efficacious for preinduction cervical ripening. Misoprostol use resulted in a significantly shorter induction-to-delivery time compared with prostaglandin E-2 gel use. The side effects associated with misoprostol may be dose related, and further studies to identify the optimum dosage and interval are needed.