Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern Galilee Hospital-Nahariya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years or older
Singleton pregnancy
Gestational age 37-42 weeks
Cephalic presentation
Disqualifiers
Multiple gestation
Known major fetal anomalies
Intrauterine fetal demise (IUFD)
Contraindication to vaginal delivery
Trial design
Design model
Parallel
Treatments tested in this trial
Carbetocin 100 Microgram/mL Solution for Injection
DrugParticipants 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
DrugParticipants 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.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Carbetocin armExperimental treatment 1 intervention
Group B: Misoprostol armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postpartum hemorrhage (PPH)
Postpartum hemorrhage defined as estimated blood loss ≥1,000 mL within 24 hours after vaginal delivery, or any bleeding associated with hemodynamic instability requiring medical or surgical intervention, according to institutional protocol.
Time frame
Within 24 hours after delivery2
Need for additional uterotonic treatment or surgical intervention
Requirement for additional uterotonic agents (including oxytocin infusion, methylergonovine, carboprost, or misoprostol), uterine massage, uterine revision, or surgical intervention for management of postpartum bleeding.
Time frame
Within 24 hours of deliverySecondary outcomes
1
Change in hemoglobin level
Difference between pre-delivery and post-delivery hemoglobin concentration, measured in g/dL.
Time frame
From admission to 24-48 hours postpartum2
Blood transfusion requirement
Administration of packed red blood cells or other blood products during or after delivery.
Time frame
Up to 24-48 hours postpartum3
Maternal adverse effects related to study medications
Occurrence of maternal side effects including diarrhea, shivering, headache, facial flushing, nausea, or vomiting following administration of study medications.
Time frame
Within 24 hours after deliveryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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