Randomized study of vaginal misoprostol (PGE(1)) and dinoprostone gel (PGE(2)) for induction of labor at term.

OBJECTIVES: To investigate the efficacy and safety of misoprostol in the induction of labor at term by comparing this agent with the commonly used dinoprostone gel.

PATIENTS AND METHODS: A randomized clinical trial of vaginal misoprostol, 50 microg 6-hourly, and dinoprostone gel, 1-2 mg 6-hourly, in 435 women undergoing induction of labor at term. The women, 210 in the misoprostol group and 225 in the dinoprostone group, were compared to determine whether there was a significant difference in achieving vaginal delivery within 24 h, the incidence of hyperstimulation syndrome, Cesarean section rate and adverse neonatal outcome. They were also offered the option of preinduction sonographic cervical assessment.

RESULTS: Misoprostol, compared to dinoprostone gel, was associated with a significantly shorter median induction-to-delivery interval (14.6 h vs. 19.0 h; P = 0.0014), a higher incidence of vaginal delivery within 24 h of induction (65.7% vs. 54.2%; P = 0.019) and a reduced need for oxytocin augmentation during labor (20.5% vs. 29.8%; P = 0.034). The groups did not differ significantly in the rates of Cesarean section (18.1% vs. 19.1%; P = 0.88) and hyperstimulation syndrome (2.4% vs. 0.9%; P = 0.27). None of the cases of hyperstimulation required treatment with tocolysis. All nine cases of excessive uterine contractility occurred after the first dose of the drug. There were no significant differences in maternal and neonatal morbidity between the two groups. There was a significant association between preinduction cervical length and the induction-to-delivery interval in both those receiving misoprostol and those treated with dinoprostone.

CONCLUSIONS: The use of misoprostol is associated with a shorter duration of labor and a higher rate of vaginal delivery within 24 h from induction without an increase in maternal and neonatal morbidity. Transvaginal sonographic measurement of cervical length is useful in the prediction of the likelihood of vaginal delivery within 24 h of induction and of the induction-to-delivery interval and may be useful in the stratification of patients participating in randomized studies that examine the effectiveness of inducing agents.