A randomized comparison of oral mifepristone to intravenous oxytocin for labor induction in women with prelabor rupture of membranes beyond 36 weeks' gestation.

Abstract

This study was undertaken to compare the use of oral mifepristone with intravenous oxytocin for labor induction in women with prelabor rupture of membranes (PROM) at 36 weeks' or greater gestational age. Sixty-five women with spontaneous PROM were randomly assigned to receive orally administered mifepristone or oxytocin infusion. Two hundred milligrams of mifepristone was administered, and subjects were observed for 18 hours, or intravenous oxytocin was administered. Thirty-three women received mifepristone and 32 received oxytocin. The average interval from start of induction to delivery was 1194.1 +/- 568.7 minutes for mifepristone-treated subjects and 770.8 +/- 519.9 minutes for oxytocin-treated subjects ( P = .001, log-transformed data). Of 33 mifepristone-treated subjects and 32 oxytocin-treated subjects, 25 (78.1%) and 17 (51.5%), respectively, achieved successful induction (defined as vaginal delivery within 24 hours) (relative risk [RR] 0.66, 95% CI 0.45-0.96, P = .01). There was more fetal distress in the mifepristone-treated group (9 vs 2, RR 4.36, 95% CI 1.02-18.66, P = .02), and a trend toward more cesarean births (7 vs 3, RR 2.26, 95% CI 0.64-7.99, P = .19). Eleven infants of mifepristone-treated women (33.3%) and 3 infants of oxytocin-treated women (9.4%) were admitted to the neonatal intensive care unit (RR 3.56, 95% CI 1.09-11.58, P = .02). Oral mifepristone administration 18 hours before oxytocin infusion did not improve labor stimulation in women with PROM near term, and was associated with more adverse fetal outcomes.