Randomization of vaginal and sublingual misoprostol for cervical ripening and labor induction

Abstract

Background: Planned induction of labor for various indications has become an established part of modern Obstetric practice. While the efficacy of misoprostol, a prostaglandin E1 analog as a cervical ripening labor induction agent has been established, the appropriate route and dosage are still objected to ongoing research. Objective: This study aims at comparing the efficacy of vaginally administered with sublingual misoprostol for cervical ripening and labor induction. Methodology: One hundred (100) pregnant women at term who fulfill the inclusion criteria were equally randomized into the two arms of the study to receive either 25 μg of misoprostol sublingually or 25μg vaginally. The induction delivery interval and fetal outcomes were compared in the two arms of the study. Results: The vaginal group required more doses of misoprostol than the sublingual group (1.68 ± 0.74 versus 1.26 ± 0.44, P = 0.005). Time from the administration of the first dose of misoprostol to the achievement of a Bishop score of 7 or active phase labor was shorter in the sublingual group than the vaginal route group (5.04 ± 1.77 hours versus 6.32 ± 1.36 hours, P = 0.001). Induction-delivery interval was shorter in the sublingual group than the vaginal route (10.02 ± 2.37 hours versus 11.12 ± 3.97 hours) although the difference was not statistically significant (P = 0.098). The mean Apgar scores at 1 min and 5 min were slightly better in the vaginal group than the sublingual group but the difference did not assume statistical significance (Apgar scores at 1 minute: 7.62 ± 0.83 versus 7.72 ± 0.88, at 5 minutes: 8.94 ± 1.23 versus 9.22 ± 0.46 for the sublingual versus the vaginal group, respectively, P = 0.561). Conclusions: The two routes of sublingual and vaginal administration showed comparable safety and effectiveness for cervical ripening and induction of labor in low-risk pregnancies at term. However, the sublingual route appears to be superior in terms of easy administration and patients' satisfaction.