Actively Recruiting
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
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-06
96
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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; healthy controls require no previous diagnosis
- Patients aged 19-45 years
- Patients of normal BMI (18-30) for the healthy control group only
- Baby is 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 cesarean delivery
- Patients undergoing cesarean delivery under spinal anesthesia
You will not qualify if you...
- 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 cesarean delivery during labor
- Patients with previous uterine surgery involving myometrial dissection or more than one previous cesarean delivery
- Patients with risk factors for postpartum hemorrhage such as polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia, and previous history of postpartum hemorrhage; morbid obesity and macrosomia allowed for diabetic group
- For the healthy control group only, BMI greater than 30 or less than 18
- Maternal age over 45 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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