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Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Suspended to Recruiting
    • Primary and study completion dates: Dec 2025 to Dec 2026
    • Site details revised
    v6
  2. Stopped Trial status: Recruiting to Suspended Sponsor's reason: This was a undergraduate student project, with some preliminary results. It may or may not be continued in the future.
    • Primary and study completion dates: Dec 2024 to Dec 2025
    • Site details revised
    v5
  3. Notable Enrollment target: 24 to 96
    • Primary and study completion dates: Jul 2024 to Dec 2024
    • Eligibility criteria revised
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Mar 18, 2024
    • Site details revised
    v3
  5. Minor Start date: Feb 2024 to Mar 2024v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes. Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH. It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.
Trial Details
NCT Number NCT06285396
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)
Postpartum Hemorrhage
Related terms Diabetes Mellitus, Type 2, Diabetes, Gestational, Postpartum Hemorrhage
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov