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Cervical Ripening and Labor Induction With Intracervical Triacetin Base Prostaglandin E₂ Gel: A Placebo-Controlled Study

From the Department of Obstetrics and Gynecology, Division of Perinatal Medicine, University of Calgary, Foothills Provincial Hospital, Calgary, Alberta, Canada

Abstract

A double-blind, randomized, placebo-controlled study was undertaken to evaluate the efficacy of a single-dose, shelf-stable preparation of prostaglandin E₂ gel (PGE₂) when used intracervically in patients with low Bishop scores. Two different preparations (0.5 and 0.25 mg) of PGE₂ were used and a total of 45 patients were studied. Both preparations of PGE₂ demonstrated a statistically significant increase in the spontaneous labor rate as compared with the placebo gel. Bishop scores were altered in all patients not proceeding to labor spontaneously, but the changes were most significant in the low- and high-dose groups. No significant deleterious affects were noted. The efficacy and safety of this new, sterile, and stable preparation makes it suitable for clinical use.