Induction in women with an unfavorable cervix: a randomized trial of extra-amniotic saline induction (easi) versus misoprostol

OBJECTIVE: to determine which method of cervical ripening resulted in the lowest cesarean rate (CS) in women with an unfavorable cervix. STUDY DESIGN: We randomized women undergoing an indicated induction of labor (IOL) to Misoprostol (El, 50μg q 4 hours × 3 doses ±oxytocin) or EASI and oxytocin. Eligible women had a singleton gestation, vertex presentation, intact membranes, cervical dilation (DIL) :=2cm and effacement ≤50%. The groups were stratified for oligohydramnios andor severe growth restriction. We calculated that a sample size of 240 women would be required to demonstrate a 50% reduction in the intergroup CS rate (a=0.05 and β=0.2). RESULTS: To date 206 women have been delivered (DEL): 104 EASI and 102 El. The groups were similar with respect to age, race, parity, indication for induction and gestational age (38.9±2.6 weeks). More women in the EASI group were attempting a vaginal DEL after CS (VBAC, EASI 17%, El 8%, p=0.04). The EASI group had a lower initial DIL (0.5 ± 0.5cm vs 0.8±0.6cm, p=.OOOI); however, at 12 hours the EASI group was more DIL (5.0±2.1 vs 3.5±2.4, p=.OOOI). The groups were also similar with respect to epidural use, chorioamnionitis rates, birthweights, neonatal outcomes, and endometritis rates. Variable EASI El p value CS rate (overall 21%) 26% 18% 0.15 CS rate excluding VBAC 20% 17% 0.5 Time insertion to DEL 17±8 19±11 0.6 (hours) Time insertion to vaginal 16±8 17±8 0.4 DEL % DEL<24 hrs (overall 81%) 85 77 O.I CONCLUSIONS: In this trial of women undergoing an indicated IOL with an unfavorable cervix, the CS rate was only 21%, and 81% of women delivered at < 24 hours. Both methods appear to be safe and efficacious in this group of women at high risk for CS and prolonged IOL.