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
Rouben, D.; Arias, F.
Obstetrics and Gynecology 82(2): 290-294
1993
ISSN/ISBN: 0029-7844 PMID: 8336880 Document Number: 417315
Objective: To compare the efficacy of extra-amniotic saline solution infusion plus an intracervical Foley catheter balloon versus 2.85 mg prostaglandin (PG) E-2 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 PGE-2 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 of 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 PGE, vaginal gel in 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 be responsible for the high incidence of cesarean in patients with an unfavorable cervix.