Comparing carbetocin and oxytocin to prevent postpartum bleeding after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Predicting the risk of postpartum hemorrhage during childbirth

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• Investigating how oxytocin works during cesarean deliveries

  This study is testing how oxytocin works during scheduled cesarean deliveries to see if it helps prevent complications like uterine atony in new mothers.

  Recruiting Phase 2 Stanford University · Stanford, California and 1 other locations · NCT05488457

• Using Tranexamic Acid to Prevent Postpartum Hemorrhage

  This study is testing if Tranexamic Acid can help prevent heavy bleeding after childbirth in women having cesarean sections or vaginal deliveries.

  Recruiting at 2 sites Phase 2 Inova Health Care Services · Washington D.C., District of Columbia and 1 other locations · NCT05370820

• Pre-eclampsia risk in pregnancies after oocyte donation

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  Recruiting at 6 sites Copenhagen University Hospital, Hvidovre · Copenhagen and 5 other locations · NCT07263490

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.