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Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

Post Partum Hemorrhage

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.

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Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 to 50

Participation 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

Study Location

Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Mrinalini Balki, MD

[email protected]
416-586-4800
Study Sponsored By
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Participants Required
More Information
Study ID: NCT06333340