NCT06333340 Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
| NCT ID | NCT06333340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Condition | Post Partum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-01-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Mrinalini Balki, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT06333340 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Post Partum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06333340 currently recruiting?
Yes, NCT06333340 is actively recruiting participants. Contact the research team at mrinalini.balki@uhn.ca for enrollment information.
Where is the NCT06333340 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06333340 clinical trial?
NCT06333340 is sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. The principal investigator is Mrinalini Balki, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 160 participants.