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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 2026v8
  2. Start date changed from estimate of Nov 2024 to Jan 14, 2025v7
  3. Primary and study completion dates: Jul 2025 to Dec 2025
    • Start date: Oct 2024 to Nov 2024
    • Secondary endpoints: 24 to 25
    v6
  4. Start date: Sep 2024 to Oct 2024v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Start date: May 2024 to Sep 2024
    • Primary and study completion dates: Mar 2025 to Jul 2025
    • Secondary endpoints: 23 to 24
    • Site details revised
    • Eligibility criteria shortened, about 4 words
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 2024 to May 2024v3
  2. Start date: Mar 2024 to Apr 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06333340
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)		 Post Partum Hemorrhage
Related terms Postpartum Hemorrhage
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov