Attempted vaginal birth after cesarean section: a multicenter comparison of outpatient prostaglandin E(2) gel with expectant management.

Pharmacia-Upjohn, Michigan, Kalamazoo, USA

Objective: To compare the clinical effectiveness and safety of outpatient administration of an intracervical prostaglandin (PG) E(2) gel with expectant management for women with an unfavorable cervix who wish to attempt a vaginal birth after cesarean section.Study Design: This outpatient study was a randomized, multicenter investigation involving pregnant women at term with one previous low transverse cesarean section. Each had an unfavorable cervix (Bishop score </=4) and was a candidate for vaginal delivery. Those randomly assigned to receive the gel, rather than expectant management, were given a 0.5 mg dose of PGE(2) (Prepidil) intracervically at 39 weeks gestation. This cervical ripening treatment was repeated at weekly office visits for up to 3 doses.Results: Of the 294 cases, 143 received the gel while 151 underwent expectant management. No differences between the two groups were found for maternal demographics, race, parity, or predose Bishop score. The rates of repeat cesarean section did not differ (P =.68) with use of the gel (61, 42%) or with expectant therapy (48, 45%). The onset of active labor, the duration of labor among those delivering vaginally, and the 1-minute and 5-minute Apgar scores were not different between the two groups. No uterine rupture was apparent, and adverse effects during labor were as likely to occur in the two groups.Conclusions: Although its safety was confirmed for outpatient use and for persons with a prior cesarean delivery, intracervical prostaglandin E(2) gel did not improve the chance of a vaginal birth after a cesarean delivery.

PMID: 10838341 [PubMed - as supplied by publisher]