Randomized trial between two active labor management protocols in the presence of an unfavorable cervix

Abstract

Objective: The purpose of this study was to compare the efficacy of two protocols for active management of labor at term in the presence of an unfavorable cervix.

Study design: Pregnancies that underwent labor induction at > or =37 weeks of gestation with an unfavorable cervix (Bishop score, < or =6) were randomly assigned to receive vaginally either a single dose of sustained-release dinoprostone (Cervidil) with concurrent low-dose oxytocin or multidosing of misoprostol (25 microg every 4 hours) followed by high-dose oxytocin. The primary outcome was the time interval from induction to vaginal delivery. Other parameters included excess uterine activity and cesarean delivery rates.

Results: A total of 151 patients (dinoprostone, 74 patients; misoprostol, 77 patients) were enrolled. The mean time from the initiation of induction to vaginal delivery was the same in the dinoprostone and misoprostol groups (15.7 hours; 95% CI, 13.7-17.7 hours vs 16.0 hours; 95% CI, 14.1-17.8 hours; P=.34), regardless of parity. The dinoprostone and misoprostol groups did not differ statistically in the percent of patients who were delivered vaginally by 12 hours (36.2% vs 29.7%), 18 hours (63.8% vs 56.3%), and 24 hours (81.0% vs 81.3%). Excess uterine activity was not more common in either group, and hyperstimulation syndrome was absent in all cases. Primary cesarean delivery rates were similar (dinoprostone, 21.6%; misoprostol, 16.9%; relative risk, 1.3; 95% CI, 0.7-2.5), with a failed induction that occurred in one case in each group.

Conclusion: Sustained-release dinoprostone with concurrent low-dose oxytocin and intermittent misoprostol with delayed high-dose oxytocin are effective alternatives for active management of labor with an unfavorable cervix.