A RANDOMIZED TRIAL OF 2 PREPARATIONS OF VAGINAL PROSTAGLANDIN FOR PREINDUCTION CERVICAL RIPENING

Objective: To compare two prostaglandin (PG) E(2) preparations for pre -induction cervical ripening in a randomized clinical trial. Methods: Two milligrams of vaginal PGE(2) gel was compared with a vaginal PGE(2 ) 3-mg tablet in 200 nulliparous women. Outcomes assessed were inducti on failure, need for labor augmentation, pain relief requirements, fet al heart rate (FHR) abnormalities, operative delivery rate, induction- to-delivery interval, neonatal condition, and occurrence of uterine hy perstimulation. Results: There was no statistical difference in pre- a nd post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.1 5-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi(2) = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative d elivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in t he overall rate of failed induction, cesarean delivery, rate of assist ed delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition. Conclusions : When compared with the PGE, tablet, the use of PGE, gel for cervical ripening and labor induction in nulliparous women did not result in s ignificant improvements in labor outcome. Whereas the gel was associat ed with an increase in significant FHR abnormalities, the tablet was a ssociated with an increase in the rate of operative delivery for poor progress in labor.