Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage

NCT07401524 | Recruiting Phase 4

• 1 other identifier: SMC-26-2925
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the drug carbetocin works better than standard care to prevent heavy bleeding after childbirth in people carrying twin pregnancies. Heavy bleeding after delivery, also called postpartum hemorrhage, is more common after twin births and can lead to anemia, blood transfusions, and other serious health problems. In this study, bleeding will be evaluated by measuring how much blood hemoglobin levels drop from before delivery to the day after delivery. The main questions this study aims to answer are:

• Does giving carbetocin after delivery lower blood loss compared with standard oxytocin treatment?
• Is carbetocin safe and practical to use in twin deliveries? Researchers will compare carbetocin to standard oxytocin treatment to see which approach better prevents bleeding after twin vaginal or cesarean delivery. Participants will:
• Be randomly assigned to receive either carbetocin or standard oxytocin after the second twin is delivered
• Have blood tests before delivery and on the day after delivery
• Be followed during their hospital stay and for up to six weeks after delivery for safety outcomes

Conditions

Postpartum Hemorrhage; Twin Pregnancy

Keywords

Carbetocin; Oxytocin; Twin Delivery; Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Change in maternal hemoglobin level from baseline to postpartum

  The primary outcome is the change in maternal hemoglobin level, defined as the difference between pre-delivery hemoglobin and hemoglobin measured on the day after delivery.

  The most recent hemoglobin measurement taken within 30 days prior to delivery to the day after delivery.

Secondary Outcomes (19)

• Estimated Blood Loss Measured by Quantitative Clinical Assessment

  During delivery (vaginal delivery or cesarean delivery)

• Number of Participants With Early Postpartum Hemorrhage

  From delivery up to 24 hours postpartum.

• Number of Participants With Late Postpartum Hemorrhage

  From 24 hours postpartum up to 6 weeks postpartum.

• Number of Participants Requiring Additional Uterotonic Administration

  From delivery up to 6 weeks postpartum

• Number of Participants Receiving Tranexamic Acid

  From delivery up to 6 weeks postpartum

Study Arms (2)

Carbetocin

EXPERIMENTAL

Participants in this arm will receive a single intravenous dose of carbetocin immediately after delivery of the second twin, as prophylaxis for postpartum hemorrhage, following either vaginal or cesarean delivery.

Drug: Carbetocin

Oxytocin (Standard Care)

ACTIVE COMPARATOR

Participants in this arm will receive standard prophylactic oxytocin according to institutional protocol, following either vaginal or cesarean delivery.

Drug: Oxytocin

Interventions

Carbetocin DRUG

Carbetocin will be administered as a single intravenous dose immediately following delivery of the second twin, according to institutional protocol, for the prevention of postpartum hemorrhage.

Carbetocin

Oxytocin DRUG

Oxytocin will be administered intravenously according to standard institutional practice, for the prevention of postpartum hemorrhage.

Oxytocin (Standard Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant individuals aged ≥18 years
• Twin pregnancies
• Gestational age ≥23 weeks

You may not qualify if:

• Known hypersensitivity or contraindication to carbetocin
• Higher-order multiple gestation (triplets or more)
• Maternal age \<18 years
• Known placenta accreta spectrum
• Known bleeding disorder
• Intrauterine fetal death of one or more fetuses
• Hyponatremia precluding oxytocin use
• Planned delivery at a non-participating hospital

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Oxytocin

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)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Avihu Krieger, MD

CONTACT

+972547421909; avihuey@gmail.com

Tal Cahan, MD

CONTACT

+972528305662; Tal.Cahan@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Physician, Department of Obstetrics and Gynecology

Model Details: Parallel-group, single-center randomized controlled trial with 1:1 allocation comparing prophylactic carbetocin versus standard oxytocin administered immediately after delivery of the second twin (vaginal or cesarean).

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 10, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)