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

NCT06285396 · tracked via the Priya Life Science Canada tracker

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Phase

Not applicable

Started

2024-03-18

Last updated

2026-04-06

Condition(s) studied

Postpartum Hemorrhage

Investigational drug(s) / intervention(s)

Ephedrine →Phenylephrine →Norepinephrine →Oxytocin →

Ephedrine: Ephedrine in solution, at applicable concentrations based on literature.

Phenylephrine: Phenylephrine, at applicable concentrations based on literature.

Norepinephrine: Norepinephrine, at applicable concentrations based on literature.

Oxytocin: Oxytocin, at applicable concentrations based on literature.

Study 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

FEMALE

Min age

19 Years

Max age

45 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Patients who have given consent to participate in the study * Patients with gestational age 37-41 weeks * Patients previously diagnosed with either Type II or Gestational diabetes. For the healthy control group, no previous diagnosis is required for inclusion * Patients of 19-45 years * Patients of normal BMI (18-30 BMI) for the healthy control group only * Baby is registered as normal weight for size for the healthy control group only * Non-laboring patients, not exposed to exogenous oxytocin * Patients requiring elective primary or first repeat caesarean delivery * Patients undergoing caesarean delivery under spinal anesthesia Exclusion Criteria: * Patients who refuse to give written informed consent * Patients who require general anesthesia * Patients in labor and those receiving oxytocin for induction of labor * Emergency caesarean delivery in labor * Patients who have had previous uterine surgery involving myometrial dissection or \>1 previous caesarean delivery * Patients with risk factors for PPH such as those with polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia (large for size baby), and previous history of PPH. However, for diabetic group, those with morbid obesity and macrosomia will not be excluded as these conditions are almost always associated with diabetes. * For the healthy control group only, a BMI \>30 or \<18 * Maternal age \>45

Primary outcome measure(s)

Motility index — 4 hours
Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.

Trial sites (1)

Facility	City	Region	Status
Mount Sinai Hospital	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06285396 on ClinicalTrials.gov ↗ ← All trials in Canada