Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage

What Was Tested

The trial (phase 4) is built around Oxytocin and Carbetocin.

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.

It had two arms (groups): Carbetocin (experimental) and Oxytocin (Standard Care) (active comparator).

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

The registry classes the interventions as drug.

More on the Plan

Postpartum hemorrhage is a major cause of maternal morbidity worldwide and occurs more frequently in twin pregnancies compared with singleton deliveries.

However, data specific to twin pregnancies are limited, and no randomized controlled trial has directly compared carbetocin with standard oxytocin prophylaxis in a twin population including both vaginal and cesarean deliveries.

Pregnant individuals aged 18 years or older with twin pregnancies delivering at or beyond 23 weeks of gestation will be eligible to participate.

Following written informed consent, participants will be randomized in a 1:1 ratio to receive either carbetocin or standard oxytocin immediately after delivery of the second twin.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant individuals aged ≥18 years. Gestational age ≥23 weeks.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: known hypersensitivity or contraindication to carbetocin; higher-order multiple gestation (triplets or more); maternal age \<18 years.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-05-05 with completion listed for 2028-03-01.

It ran at 1 site in Israel.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 19 secondary outcomes, for example Estimated Blood Loss Measured by Quantitative Clinical Assessment, Number of Participants With Early Postpartum Hemorrhage, Number of Participants With Late Postpartum Hemorrhage, Number of Participants Requiring Additional Uterotonic Administration, Number of Participants Receiving Tranexamic Acid and Number of Participants Receiving Blood Product Transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page and the Carbetocin compound page, all human trials.