Actively Recruiting
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-01
160
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH. This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa. The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.
CONDITIONS
Official 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 undergoing elective cesarean delivery
- Age between 18 and 50 years
- Presence of one or more risk factors for uterine atony including:
- Polyhydramnios (amniotic fluid index >24 cm)
- Large baby (>90th percentile or >4000 gm on ultrasound)
- Multiple gestation
- History of uterine atony or postpartum hemorrhage with blood loss >1000 ml or surgical intervention
- Obesity with BMI >40 kg/m2
- Diabetes mellitus under treatment
- Preeclampsia under treatment
- Placenta previa
You will not qualify if you...
- Valvular heart disease, arrhythmias, or heart failure
- Placenta accreta spectrum
- Bleeding disorder
- Anemia with hemoglobin <100 g/dl
- Allergy or sensitivity to oxytocin or carbetocin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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