Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
Starting soon · Not applicable
Conditions studied: Postpartum Complication, Postpartum Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT07353281
- Run by
- Western Galilee Hospital-Nahariya
- People needed
- 146
- Starts
- 2026-01-31
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 18 years or older
- Singleton pregnancy
- Gestational age 37-42 weeks
- Cephalic presentation
- Vaginal delivery
- Presence of one or more risk factors for postpartum hemorrhage, including:
- Grand multiparity (≥5 previous deliveries)
- History of postpartum hemorrhage
- History of manual removal of placenta
- Estimated fetal weight ≥4,000 grams
- Polyhydramnios
- Chorioamnionitis
- Prolonged oxytocin use during labor (third augmentation cycle or more)
- Eligible for prophylactic uterotonic therapy after delivery
- Provided written informed consent
You may not qualify if…
- Multiple gestation
- Known major fetal anomalies
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Known hypersensitivity to carbetocin, misoprostol, or oxytocin
- Known coagulation disorders requiring alternative management
- Planned cesarean delivery
- Participation in another interventional study that may affect postpartum bleeding outcomes
Full record on ClinicalTrials.gov
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