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RECRUITING
NCT06285396
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

19 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-03-18

Completion Date

2026-12

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

DRUG

Ephedrine

Ephedrine in solution, at applicable concentrations based on literature.

DRUG

Phenylephrine

Phenylephrine, at applicable concentrations based on literature.

DRUG

Norepinephrine

Norepinephrine, at applicable concentrations based on literature.

DRUG

Oxytocin

Oxytocin, at applicable concentrations based on literature.

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada