Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage

Short name CUTT-PPH

NCTNCT07401524Other idSMC-26-2925

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 120 participants (estimated)
Sponsor: Sheba Medical Center · Other gov
Design: Randomized · Open label (no masking)
Countries: 1 country
Israel
Start: 5 May 2026
Primary completion: 1 Mar 2028 (estimated)
Completion: 1 Dec 2028 (estimated)
First posted: 10 Feb 2026
Last update posted: 8 May 2026
Conditions: Postpartum Hemorrhage · Twin Pregnancy

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 4
CUTT-PPH
NCT07401524
5 May 2026 to est. 1 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

CarbetocinDrug
OxytocinDrug

Arms2

Experimental
Carbetocin
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.
Active comparator
Oxytocin (Standard Care)
Participants in this arm will receive standard prophylactic oxytocin according to institutional protocol, following either vaginal or cesarean delivery.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in maternal hemoglobin level from baseline to postpartum
Time frame · The most recent hemoglobin measurement taken within 30 days prior to delivery to the day after delivery.
Registry description
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.

Secondary outcomes(19)

Estimated Blood Loss Measured by Quantitative Clinical Assessment
Time frame · During delivery (vaginal delivery or cesarean delivery)
Registry description
Estimated blood loss during delivery, assessed using standard quantitative clinical methods as documented in the medical record.
Number of Participants With Early Postpartum Hemorrhage
Time frame · From delivery up to 24 hours postpartum.
Registry description
Early postpartum hemorrhage defined as quantitative blood loss \>500 mL after vaginal delivery or \>1000 mL after cesarean delivery.
Number of Participants With Late Postpartum Hemorrhage
Time frame · From 24 hours postpartum up to 6 weeks postpartum.
Registry description
Late postpartum hemorrhage defined as quantitative blood loss \>500 mL after vaginal delivery or \>1000 mL after cesarean delivery.
Number of Participants Requiring Additional Uterotonic Administration
Time frame · From delivery up to 6 weeks postpartum
Number of Participants Receiving Tranexamic Acid
Time frame · From delivery up to 6 weeks postpartum
Number of Participants Receiving Blood Product Transfusion
Time frame · From delivery up to 6 weeks postpartum.
Number of Blood Products Transfused
Time frame · From delivery up to 6 weeks postpartum.
Post delivery day 1 hemoglobin level.
Time frame · Post delivery day 1
Number of Participants Requiring Intrauterine Balloon Tamponade
Time frame · From delivery up to 6 weeks postpartum
Use of uterine compression sutures (e.g., B-Lynch suture).
Time frame · From delivery up to 6 weeks postpartum.
Number of Participants Undergoing Hysterectomy
Time frame · From delivery up to 6 weeks postpartum.
Number of Participants Admitted to the Intensive Care Unit
Time frame · From delivery up to 6 weeks postpartum.
Registry description
Admission to an intensive care unit for maternal indications as documented in the medical record.
Number of Participants With Maternal Postpartum Infections
Time frame · From delivery up to 6 weeks postpartum.
Registry description
Includes postpartum fever, endometritis, urinary tract infection, mastitis, and surgical site infection.
Maternal death.
Time frame · From delivery up to 6 weeks postpartum.
Length of postpartum hospitalization.
Time frame · From delivery up to 6 weeks postpartum
Number of Participants Re-admitted Within 6 Weeks Postpartum Due to Bleeding
Time frame · From delivery up to 6 weeks postpartum.
Number of Participants Requiring Additional Surgical Intervention Within 6 Weeks Postpartum
Time frame · From delivery up to 6 weeks postpartum.
Number of Participants Breastfeeding at 6 Weeks Postpartum
Time frame · 6 weeks postpartum.
Side effects and adverse outcomes
Time frame · From delivery up to 24 hours postpartum

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Pregnant individuals aged ≥18 years * Twin pregnancies * Gestational age ≥23 weeks Exclusion Criteria: * 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

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