Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention

NCT07353281 | Not Yet Recruiting

• 1 other identifier: 0206-25-NHR
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postpartum Complication; Postpartum Hemorrhage

Keywords

Postpartum hemorrhage, Carbetocin, Misoprostol, Vaginal delivery, Uterotonic agents, High-risk pregnancy

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 24 hours after delivery

• 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.

  Within 24 hours of delivery

Secondary Outcomes (3)

• Change in hemoglobin level

  From admission to 24-48 hours postpartum

• Blood transfusion requirement

  Up to 24-48 hours postpartum

• Maternal adverse effects related to study medications

  Within 24 hours after delivery

Study Arms (2)

Carbetocin arm

EXPERIMENTAL

Participants in this arm will receive intravenous carbetocin (100 micrograms) immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. Carbetocin will be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.

Drug: Carbetocin 100 Microgram/mL Solution for Injection

Misoprostol arm

ACTIVE COMPARATOR

Participants in this arm will receive rectal misoprostol (1000 micrograms) immediately after placental delivery, in addition to intravenous oxytocin, for the prevention of postpartum hemorrhage following vaginal delivery. This regimen represents an accepted uterotonic prophylaxis strategy for women at increased risk for postpartum hemorrhage.

Drug: Misoprostol

Interventions

Misoprostol DRUG

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.

Misoprostol arm

Carbetocin 100 Microgram/mL Solution for Injection DRUG

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.

Carbetocin arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is limited to pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Related Publications (4)

• Albazee E, Alrashidi H, Laqwer R, Elmokid SR, Alghamdi WA, Almahmood H, AlGhareeb M, Alfertaj N, Alkandari DI, AlDabbous F, Alkanderi J, Al-Jundy H, Abu-Zaid A, Alomar O. Intravenous Carbetocin Versus Rectal Misoprostol for the Active Management of the Third Stage of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cureus. 2022 Oct 12;14(10):e30229. doi: 10.7759/cureus.30229. eCollection 2022 Oct.

  PMID: 36246091 RESULT

• Delavallade M, Vaunois A, Cellier M, Boukerfa-Bennacer Y, Chauleur C, Raia-Barjat T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage during caesarean section in patients at high risk of bleeding. Eur J Obstet Gynecol Reprod Biol. 2024 Sep;300:206-210. doi: 10.1016/j.ejogrb.2024.07.015. Epub 2024 Jul 8.

  PMID: 39029242 RESULT

• Rath W. Prevention of postpartum haemorrhage with the oxytocin analogue carbetocin. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):15-20. doi: 10.1016/j.ejogrb.2009.06.018. Epub 2009 Jul 17.

  PMID: 19616358 RESULT

• Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

  PMID: 28937571 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Injections; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Nadir Ganem, Dr.

CONTACT

04-910-7107; nadirg@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share