Comparing carbetocin and oxytocin to prevent postpartum bleeding after cesarean delivery
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
This study is testing whether carbetocin works better than oxytocin to prevent heavy bleeding after a cesarean delivery in women who are at higher risk for this complication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06333340 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two medications, carbetocin and oxytocin, in preventing postpartum hemorrhage (PPH) in women undergoing elective cesarean delivery who are at increased risk for this complication. The trial focuses on patients with risk factors such as multiple gestation, large baby, and obesity, among others. By administering these medications, the study seeks to determine which is more effective in reducing the incidence of PPH. The hypothesis is that carbetocin will outperform oxytocin in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women undergoing elective cesarean delivery who have one or more risk factors for postpartum hemorrhage.
Not a fit: Patients with conditions such as heart disease, bleeding disorders, or allergies to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for postpartum hemorrhage, potentially saving lives and reducing maternal morbidity.
How similar studies have performed: Other studies have suggested that carbetocin may be more effective than oxytocin in preventing postpartum hemorrhage, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria - Any one or more of the risk factors for uterine atony: * Overdistended uterus due to: * Polyhydramnios (amniotic fluid index \>24 cm) * Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm * Multiple gestation * History of uterine atony/PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization) * Obesity with body mass index (BMI) \>40 kg/m2 * Diabetes mellitus on treatment * Preeclampsia on treatment * Placenta previa Exclusion criteria: * Valvular heart disease, arrhythmias, or heart failure * Placenta accreta spectrum * Bleeding disorder * Anemia (\<100 g/dl) * Allergy or sensitivity to oxytocin or carbetocin
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
- Study coordinator: Mrinalini Balki, MD
- Email: mrinalini.balki@uhn.ca
- Phone: 416-586-4800
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.