OBJECTIVE: To assess efficacy of the Foley catheter compared with the dinoprostone vaginal insert for beginning labor inductions at or near term.
METHODS: We performed a multicenter randomized controlled trial. We enrolled women at 36 weeks of gestation or greater with a singleton live fetus in cephalic presentation, intact membranes, an unfavorable cervix (dilation less than 3 cm; if 2 cm, less than 80% effaced), and no contraindication to labor or either study agent. Women were allocated to either a cervical Foley catheter inflated to 30 mL or dinoprostone 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 delivery by 24 hours, vaginal delivery by 24 hours, time to vaginal delivery, cesarean delivery rate, and rate of tachysystole. Analysis was by intent-to-treat.
RESULTS: We enrolled 376 patients, 185 allocated to Foley catheter and 191 to dinoprostone. In the Foley catheter group, time to delivery was shorter (median 21.6 compared with 26.6 hours; P=.003), more patients delivered within 24 hours (56% compared with 40%; P=.003), more delivered vaginally within 24 hours (44% compared with 30%; P=.004), and time to vaginal delivery was shorter (median 20.1 compared with 24.3 hours; P=.005). The cesarean delivery rates were 29% compared with 39% (P=.07). Uterine tachysystole occurred in 0% compared with 3% (P=.06).
CONCLUSION: Starting labor inductions with a Foley catheter, compared with the dinoprostone vaginal insert, results in a shorter time to delivery and a higher proportion of women delivered and delivered vaginally within 24 hours. Cesarean delivery rates were not statistically significantly different.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01402050.
LEVEL OF EVIEDENCE: I