A Randomized Trial of Extra-Amniotic Saline Infusion Plus Intracervical Foley Catheter Balloon Versus Prostaglandin E2 Vaginal Gel for Ripening the Cervix and Inducing Labor in Patients With Unfavorable Cervices

Objective: To compare the efficacy of extra-amniotic saline solution infusion plus an intracervical Foley catheter balloon versus 2.85 mg prostaglandin (PG) E2 vaginal gel in ripening the cervix, inducing labor, and achieving vaginal delivery in patients at term with an unfavorable cervix. Methods: A randomized study of the two methods was performed in 112 patients with a Bishop score of 5 or less. Results: Extra-amniotic saline infusion plus intracervical Foley catheter balloon was more effective than PGE2 vaginal gel in causing cervical ripening (relative risk [RR] 2.5965, 95% confidence interval [CI] 1.7277–3.9022, exact two-tailed P = .000001) and in inducing labor (RR 4.3333, 95% CI 1.7223–10.9026, exact two-tailed P = .0000181). However, the final delivery outcome was an equally high number cesarean deliveries (26 of 56, or 46.4%) for both methods. Maternal and neonatal complications were minimal and not significantly different. Conclusions: Extra-amniotic saline infusion with a Foley catheter was more effective than 2.85 mg PGE2 vaginal gel ripening the cervix and inducing labor. These advantages did not translate into a large number of vaginal deliveries, indicating that factors other than cervical ripening may responsible for the high incidence of cesarean in patients with an unfavorable cervix.