Actively Recruiting
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-01
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying postpartum hemorrhage (PPH), a serious bleeding complication after cesarean delivery (CD), focusing on patients at higher risk for this condition. The study compares two drugs commonly used to prevent excess uterine bleeding: oxytocin and carbetocin. Carbetocin, a synthetic oxytocin analog, has a longer-lasting effect and may reduce the need for continuous infusion compared to oxytocin. The trial aims to provide evidence on their relative effectiveness and safety in high-risk patients, which could guide future treatment guidelines. Participants will be randomly assigned to receive either oxytocin or carbetocin during elective cesarean delivery. Oxytocin is given as a 5 IU intravenous dose over 1 minute followed by continuous infusion for 4 hours, while carbetocin is administered as a 100 mcg intravenous dose over 1 minute followed by a placebo infusion. Both treatments are designed to prevent uterine atony and reduce bleeding after childbirth. During the study, researchers will monitor the need for additional uterotonic agents within 90 minutes after delivery as the primary outcome. Secondary assessments include uterine tone at different time points, blood loss measurements, and various safety parameters such as blood pressure, heart rate, and symptoms like nausea or chest pain. Participants will be observed for up to 24 hours post-delivery to evaluate recovery and any complications related to bleeding or treatment. The total duration of participation covers the immediate period around the cesarean delivery and the following day.
CONDITIONS
Brief Title
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 50 years
- Undergoing elective cesarean delivery
- Have one or more risk factors for uterine atony such as polyhydramnios (amniotic fluid index >24 cm), fetal macrosomia (>90th percentile or >4000 gm), multiple gestation, history of uterine atony or postpartum hemorrhage, obesity with BMI >40 kg/m2, diabetes mellitus on treatment, preeclampsia on treatment, or placenta previa
You will not qualify if you...
- Presence of valvular heart disease, arrhythmias, or heart failure
- Placenta accreta spectrum
- Bleeding disorders
- Anemia with hemoglobin less than 100 g/dl
- Allergy or sensitivity to oxytocin or carbetocin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Approximately 4 hours
Participants receive a uterotonic drug (either carbetocin or oxytocin) during elective cesarean delivery to help prevent postpartum hemorrhage.
1 treatment visit (in-person) during cesarean delivery
Duration - 24 hours
Participants are monitored for outcomes and any adverse events up to 24 hours after delivery.
Follow-up assessments up to 24 hours post-delivery
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here