A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis

The ability of prostaglandin E2 to prepare the unripe cervix before an indicated labor induction is controversial. We therefore tested 100 pregnant women in a randomized, double-blind trial with intracervical prostaglandin E2 gel, 0.5 mg. The 53 women who received the placebo gel had an outcome similar to that of the 47 women who received the prostaglandin E2 gel. The mean change in cervical score, mean application-to-delivery interval, incidence of uncomplicated spontaneous labor, incidence of cesarean delivery for a failed induction, and the overall cesarean section rate were not significantly different for the two groups. A meta-analysis, incorporating 18 studies of 1811 patients who received a single application of at least 5 mg prostaglandin E2 gel intravaginally or 0.5 mg intracervically, demonstrated no significant decrease in the overall cesarean delivery rate (p = 0.85). We conclude that the use of single-dose intracervical prostaglandin E2 gel for cervical ripening has little effect on labor induction. Moreover, the use of single-dose intracervical or intravaginal prostaglandin E2 gel does not alter the incidence of cesarean delivery, even when large numbers of patients are analyzed by combining the results of similar reports.