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Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Notable Primary and study completion dates: Dec 2025 to Dec 2026v10
  2. Minor Primary and study completion dates: Jul 2025 to Dec 2025v9
  3. Minor Study arms: 17 to 10v8
  4. Notable Primary and study completion dates: Dec 2024 to Jul 2025
    • Enrollment target: 30 to 40
    • Study arms: 7 to 17
    v7
  5. Notable Primary and study completion dates: Dec 2023 to Dec 2024v6
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  1. Minor Primary and study completion dates: Jul 2023 to Dec 2023v5
  2. Notable Primary and study completion dates: Dec 2022 to Jul 2023v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2022 to Aug 17, 2022
    • Site details revised
    v3
  4. Notable Start date: Apr 2022 to Jun 2022v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.
Trial Details
NCT Number NCT05290129
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)
Postpartum Hemorrhage
Related terms Postpartum Hemorrhage
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov