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 ≥37 weeks of gestation with an unfavorable cervix (Bishop score, ≤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 μg 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.