drugset / Trial / NCT07353281

Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention

NCT07353281

Not yet recruiting 146 enrolled Western Galilee Hospital-Nahariya
RandomizedParallel-groupOpen-labelPrevention

Summary

Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited. This prospective randomized study aims to compare the effectiveness and safety of intravenous carbetocin versus rectal misoprostol for the prevention of postpartum hemorrhage in women with risk factors undergoing vaginal delivery at Galilee Medical Center. The primary outcome is the incidence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents or surgical interventions, changes in hemoglobin levels, blood transfusion requirements, and maternal adverse effects.

Timeline

Start
2026-01-31
Primary completion
2028-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbetocin Peptide 100 ug Intravenous
Comparator Misoprostol Other / unclassified 1000 ug Other

Indications