Carbetocin to prevent heavy bleeding after twin birth
Carbetocin Administration for the Prevention of Postpartum Hemorrhage in Twin Deliveries: A Randomized Controlled Trial
PHASE4 · Sheba Medical Center · NCT07401524
This trial tests whether a single dose of carbetocin given after the second twin is born reduces heavy bleeding compared with standard oxytocin in people delivering twins.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sheba Medical Center (other gov) |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT07401524 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized phase 4 trial at Sheba Medical Center will assign pregnant people with twin pregnancies (≥23 weeks and age ≥18) in a 1:1 ratio to receive either prophylactic carbetocin or standard oxytocin after the second twin is delivered. Blood loss will be quantified by the drop in hemoglobin from before delivery to the day after delivery, and investigators will record safety outcomes such as need for additional uterotonics, transfusion, and adverse events. The trial includes both vaginal and cesarean twin deliveries and excludes higher-order multiples, placenta accreta, bleeding disorders, and intrauterine fetal death. The primary aim is to see if carbetocin lowers postpartum blood loss and is safe and practical compared with oxytocin.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 or older with a twin pregnancy at or beyond 23 weeks who plan to deliver at Sheba Medical Center and have no contraindication to carbetocin or oxytocin.
Not a fit: Patients with known hypersensitivity to carbetocin/oxytocin, placenta accreta spectrum, bleeding disorders, hyponatremia that precludes oxytocin, intrauterine fetal death, higher-order multiples, or those planning delivery outside the participating hospital are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, carbetocin could reduce postpartum blood loss in twin deliveries and lower rates of anemia, transfusion, and related complications.
How similar studies have performed: Previous randomized trials and meta-analyses have shown carbetocin reduces the need for additional uterotonics and transfusion, primarily after cesarean delivery, but randomized data specifically in twin pregnancies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ramat Gan
- Sheba Medical Center — Ramat Gan, Israel (RECRUITING)
Study contacts
- Study coordinator: Avihu Krieger, MD
- Email: avihuey@gmail.com
- Phone: +972547421909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Hemorrhage, Twin Pregnancy, Carbetocin, Oxytocin, Twin Delivery