Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial.

OBJECTIVE: To compare titrated oral misoprostol to intravenous oxytocin for labor augmentation among women at 36 to 42 weeks of gestation with spontaneous onset of active labor.

METHODS: Women meeting the general selection criteria with regular contractions and an effaced cervix dilated between 3 and 9 cm, and who had inadequate uterine contractions (two or fewer contractions every 10 minutes) during the first stage of labor, were randomly assigned to titrated oral misoprostol or intravenous oxytocin. Augmentation-to-vaginal delivery interval and vaginal delivery within 12 or 24 hours were the primary outcomes. The data were analyzed by intention to treat.

RESULTS: Of the 231 women, 118 (51.1%) were randomized to titrated oral misoprostol and 113 (48.9%) to titrated intravenous oxytocin. The median interval from the start of augmentation to vaginal delivery was 5.22 hours (3.77-8.58 hours, 25th-75th percentile) in the misoprostol group, and 5.20 hours (3.23-6.50 hours, 25th-75th percentile) in the intravenous oxytocin group (P=.019). Complete vaginal delivery occurred within 12 hours for 92 women (78.0%) in the misoprostol group and for 97 women (85.8%) in the oxytocin group (P=.121; relative risk 0.91, 95% confidence interval 0.80-1.03). There were no significant differences between the two groups who delivered vaginally within 24 hours. Side effects and neonatal outcomes also did not differ between the two groups.

CONCLUSION: Labor augmentation with titrated oral misoprostol or intravenous oxytocin resulted in similar rates of vaginal delivery within 12 and 24 hours.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00695331.

LEVEL OF EVIDENCE: I.