A RANDOMIZED COMPARISON OF PROSTAGLANDIN E(2), OXYTOCIN, AND THE DOUBLE-BALLOON DEVICE IN INDUCING LABOR

Objective: To compare the efficacy of three methods for ripening and d ilating the unfavorable cervix for induction of labor. Methods: Pregna nt women having an indication for induction of labor with a singleton vertex fetus, intact membranes, and Bishop score of no more than 4 wer e randomized to one of three induction methods: intravaginal prostagla ndin (PG) E(2) tablets (3 mg) followed by a second dose if labor did n ot start; continuous intravenous oxytocin drip; or the Atad Ripener De vice, with inflation of both balloons and removal after 12 hours. For all patients, the cervix was assessed by the same investigator before induction and 12 hours later. Results: Thirty subjects were included i n the PGE(2) group, 30 in the oxytocin group, and 35 in the Atad Ripen er Device group. The postpartum course was comparable in all. The chan ge in Bishop score in the PGE(2) and Atad Ripener Device groups was si gnificantly better than in the oxytocin group (median and range of 5 [ 0-9] and 5 [0-7], respectively, versus 2.5 [0-9]; P <.01). Cervical di lation more than 3 cm was more frequent in the Atad Ripener Device gro up compared with both the PGE(2) and oxytocin groups (85.7 versus 50 a nd 23.3%, respectively; P <.01). The trial of induction failed in only two patients (5.7%) in the Atad Ripener Device group, compared with s ix (20%) in the PGE(2) and 16 (53.3%) in the oxytocin groups (P <.001) . Mean (+/- standard deviation) induction-to-delivery interval was 21. 3 +/- 7.0 hours in tile Atad Ripener Device group, 23.2 +/- 12.5 hours in the PGE(2) group, and 28.2 +/- 14.7 hours in the oxytocin group. T he success rate for vaginal delivery was significantly better in the A tad Ripener Device and PGE, groups compared with the oxytocin group (7 7.1 and 70%, respectively, versus 26.7%; P<.01). Conclusion: The Atad Ripener Device had a significantly better success rate for cervical di lation and a lower failure rate than those for PGE(2) and oxytocin. Th e PGE(2) and Atad Ripener Device groups had better results than the ox ytocin group in regard to Bishop score change and induction-to-deliver y interval. The Atad Ripener Device may be a superior method for cervi cal ripening and labor induction in patients with unfavorable cervices .