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To assess the efficacy of the Foley catheter compared to the 10 mg controlled release prostaglandin E2 vaginal insert (PGE2) for cervical ripening in term and near term women presenting for labor induction.
We performed a multicenter randomized controlled trial. We enrolled women at ≥36 weeks with a singleton live fetus in cephalic presentation, intact membranes, an unfavorable cervix (dilation <3 cm; if 2 cm, <80% effaced), and no contraindication to labor or either study agent. Women were randomly allocated to either a cervical Foley catheter inflated to 30 mL or PGE2 for up to 12 hours. Oxytocin was allowed only after study agent removal. The primary outcome was time from agent placement to delivery. Secondary outcomes included proportion of patients delivered by 24 hours, proportion delivered vaginally by 24 hours, time to vaginal delivery, cesarean delivery rate, indications for cesarean delivery, and maternal and neonatal complications. Analysis was by intent-to-treat.
We enrolled 376 patients, of whom 185 were allocated to Foley and 191 to PGE2. Time from agent placement to delivery was shorter in the Foley group (median 21.6 vs. 26.6 hours; p=0.003)—see figure. More patients in the Foley group were delivered within 24 hours (56% vs. 40%; p=0.003) and delivered vaginally within 24 hours (44% vs.30%; p=0.004). Time from agent placement to vaginal delivery was shorter in the Foley group (median 20.1 vs. 24.3 hours; p=0.005). The cesarean delivery rate did not differ between groups (30% vs. 38%; p=0.10). Additional data are shown in the table.
In term or near term women with an unfavorable cervix, starting labor inductions with a Foley catheter, compared to the prostaglandin E2 vaginal insert, results in shorter times from agent placement to delivery with no uterine tachysystole. Cesarean delivery rates and maternal and neonatal morbidity were comparable.