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Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
Sponsor: Western Galilee Hospital-Nahariya
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.
Official title: Carbetocin Versus Misoprostol for the Prevention of Postpartum Hemorrhage After Vaginal Delivery in Women With Risk Factors: A Prospective Randomized Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2026-01-31
Completion Date
2028-01-01
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
Carbetocin 100 Microgram/mL Solution for Injection
Participants randomized to this intervention will receive intravenous carbetocin 100 micrograms administered immediately after placental delivery as prophylaxis for postpartum hemorrhage following vaginal delivery. Carbetocin is a long-acting synthetic analogue of oxytocin and is used as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.
Misoprostol
Participants randomized to this intervention will receive rectal misoprostol 1000 micrograms immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. In accordance with standard practice, intravenous oxytocin 10 units will also be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.