Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
Status:
NOT_YET_RECRUITING
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
Summary
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery. The primary objective is to estimate the optimal effective dose (ED90) of sublingual oxytocin administered during the active management of the third stage of labor to result in satisfactory uterine tone and a cumulative blood loss \< 500 ml at 20 minutes after vaginal delivery in 90% of parturients with an acceptable safety profile.