ABSTRACT
OBJECTIVE: This study was undertaken to evaluate the efficacy and safety of intravaginal administration of glyceryl trinitrate plus dinoprostone versus dinoprostone, for cervical ripening and induction of labor. STUDY DESIGN: A prospective, double-blind, placebo-controlled, randomized clinical trial was conducted among 196 singleton low-risk nullipara women with term pregnancies and unfavorable cervices who were randomly assigned to receive intravaginal glyceryl trinitrate plus dinoprostone or placebo plus dinoprostone. The main outcome variables were time from application to active phase of labor and to delivery. Secondary outcomes were change in Bishop score, fetal and maternal morbidity, and incidence of cesarean deliveries. RESULTS: The interval from application of the initial dose to the beginning of active phase of labor was 868 +/- 582 and 1136 +/- 692 minutes (P = .004) and from initial dose to delivery was 1339 +/- 826 and 1620 +/- 975 minutes (P = .03) for the glyceryl trinitrate and placebo groups, respectively. There were no significant differences in Bishop score change, cesarean section rate, and in the incidence of hypersystole and hyperstimulation. The incidence of tachysystole was significantly lower in the glyceryl trinitrate group (4% vs 15%, P < or = .02). No maternal and neonatal adverse effects were noted. CONCLUSION: The association of glyceryl trinitrate with dinoprostone is more effective than dinoprostone alone for labor induction in low-risk patients at term with unfavorable cervices.
