RecruitingNot ApplicableNCT06285396

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


Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Enrollment

96 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ephedrine, a drug called Norepinephrine, and others for people with postpartum hemorrhage. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEphedrine

Ephedrine in solution, at applicable concentrations based on literature.

DRUGPhenylephrine

Phenylephrine, at applicable concentrations based on literature.

DRUGNorepinephrine

Norepinephrine, at applicable concentrations based on literature.

DRUGOxytocin

Oxytocin, at applicable concentrations based on literature.


Locations(1)

Mount Sinai Hospital

Toronto, Ontario, Canada

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NCT06285396


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