Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial.

INTRODUCTION

The aim of this study was to compare the efficacy and safety of a low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

MATERIAL AND METHODS

We designed a prospective, randomized, open-labeled trial with evaluators blinded to the end-point, including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and a Bishop score <6. They were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable. A P value <0.05 was considered statistically significant. This study was registered in ClinicalTrials.gov (number NTC03744364).

RESULTS

We included 198 women for analysis (99 women in each group). Vaginal birth rate within 24 hours did not differ between groups (49.5% vs 42.4%; P = 0.412). When the Bishop score was <4, dinoprostone insert showed a higher probability of vaginal delivery within 12 hours (17.8% vs 4%; P = 0.012). In the dinoprostone group, removal of the insert was more likely to be due to an adverse event (5.1% vs 14.1%; P = 0.051) and an abnormal fetal heart rate pattern during active labor (44.4% vs 58.6%; P = 0.047). Both groups were similar in neonatal outcomes including Apgar score, umbilical cord pH and neonatal intensive care unit admission.

CONCLUSIONS

Low-dose vaginal misoprostol and vaginal dinoprostone insert seem to be equally effective and safe for induction of labor in pregnant women with a gestational age beyond 41 weeks.