Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSheba Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant individuals aged ≥18 years
Twin pregnancies
Gestational age ≥23 weeks
Disqualifiers
Known hypersensitivity or contraindication to carbetocin
Higher-order multiple gestation (triplets or more)
Maternal age <18 years
Known placenta accreta spectrum
Trial design
Design model
Parallel
Treatments tested in this trial
Carbetocin
DrugCarbetocin 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.
Oxytocin
DrugOxytocin will be administered intravenously according to standard institutional practice, for the prevention of postpartum hemorrhage.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CarbetocinExperimental treatment 1 intervention
Group B: Oxytocin (Standard Care)Active comparator 1 intervention
Trial outcomes
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.
Time frame
The most recent hemoglobin measurement taken within 30 days prior to delivery to the day after delivery.Secondary outcomes
1
Estimated Blood Loss Measured by Quantitative Clinical Assessment
Estimated blood loss during delivery, assessed using standard quantitative clinical methods as documented in the medical record.
Time frame
During delivery (vaginal delivery or cesarean delivery)2
Number of Participants With Early Postpartum Hemorrhage
Early postpartum hemorrhage defined as quantitative blood loss \>500 mL after vaginal delivery or \>1000 mL after cesarean delivery.
Time frame
From delivery up to 24 hours postpartum.3
Number of Participants With Late Postpartum Hemorrhage
Late postpartum hemorrhage defined as quantitative blood loss \>500 mL after vaginal delivery or \>1000 mL after cesarean delivery.
Time frame
From 24 hours postpartum up to 6 weeks postpartum.4
Number of Participants Requiring Additional Uterotonic Administration
Time frame
From delivery up to 6 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov