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

RecruitingNAAges 18 Years - 50 YearsFemaleSamuel Lunenfeld Research Institute, Mount Sinai …
NCT06333340 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Oxytocin
  • Carbetocin
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Where

1 site
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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