Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention (NCT07353281) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
146 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postpartum hemorrhage (PPH)
Timeframe: Within 24 hours after delivery
2
Need for additional uterotonic treatment or surgical intervention