A randomized trial comparing prostaglandin E 2 vaginal insert (Cervidil) to vaginal gel for cervical ripening before induction of labor

Abstract

Objective: To compare the efficacy and safety of a controlled release vaginal insert (Cervidil) with hospital compounded prostaglandin E 2 vaginal gel for cervical ripening before labor induction. Methods: A prospective randomized study was performed between July 1996 and August 1997 on 200 patients undergoing cervical ripening before induction of labor. The efficacy and safety of a 12-hour controlled release 10-mg vaginal insert (Cervidil, Forest Pharmaceuticals) was compared with two 4-mg doses of prostaglandin E 2 gel. Results: The study groups did not differ by parity, estimated gestational age, indications for induction, and initial Bishop scores. No differences were noted in Bishop score at 12 hours or change in Bishop score. No statistically significant differences were noted in the successful inductions, additional days of induction, and the number of patients discharged undelivered. There were no differences in mean time to active labor, cesarean section, meconium staining, 1 and 5 minute Apgar scores, cord pH values, NICU admissions, and incidence of hyperstimulation. Cervidil ( n = 88) Pg E 2 gel ( n = 88) Initial Bishop score (mean) 3.0 3.1 NS 12-h Bishop score (mean) 8.5 9.1 NS Change in Bishop score 0–12 h (mean) 5.8 6.0 NS Successful inductions 71 (80.7%) 77 (87.5%) NS Additional days of induction 27 20 NS Patients discharged undelivered 5 (5.7%) 6 (6.8%) NS Hyperstimulation 5 (5.7%) 4 (4.5%) NS Conclusions: Two 4-mg doses of prostaglandin vaginal gels are equally effective to a Cervidil vaginal insert for preinduction cervical ripening.