Mechanical cervical ripening vs. PGE1 compared for labor induction in overweight/obese women with prolonged pregnancies

A pregnancy is considered prolonged from 41 weeks of gestation, increasing risks for both mother and fetus. Maternal complications include higher rates of emergency caesarean sections, severe perineal lesions, and postpartum hemorrhage. Fetal risks involve oligohydramnios and meconium aspiration. Current standard-of-care often involves labor induction, but the optimal cervical ripening method, particularly in overweight and obese women, remains a critical clinical question. This study addresses the gap in comparing mechanical versus pharmacological approaches.

This randomized controlled trial (NCT02907060) enrolled 1224 women with prolonged pregnancies to compare cervical ripening methods. Participants were overweight and obese women undergoing labor induction. The study compared mechanical cervical ripening (using the Cook double balloon catheter) against pharmacological agents (specifically PGE1). The primary objective was to investigate whether mechanical ripening is superior or inferior to PGE1 in this specific patient population. This Phase 3 study was completed in 2018.

The provided abstract does not detail the specific findings or numerical results of this randomized controlled trial. The study's primary objective was to compare the efficacy and safety profiles of mechanical cervical ripening (Cook double balloon catheter) versus pharmacological agents (PGE1) for labor induction in overweight and obese women with prolonged pregnancies. Without the results, it is not possible to report specific percentages, p-values, or fold-changes regarding the superiority or inferiority of either method. The trial was completed in December 2018 with an actual enrollment of 1224 participants, suggesting a robust dataset was collected, but not presented here.