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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how medications used to treat low blood pressure during elective cesarean delivery (CD) affect the uterine muscle's ability to contract, especially in women with Type II and gestational diabetes. These diabetic patients face a higher risk of postpartum hemorrhage due to possible changes in uterine contractility caused by vasopressors, which are drugs given to raise blood pressure during spinal anesthesia. The study aims to compare uterine contraction patterns and receptor distribution in diabetic and healthy pregnant women using tissue samples taken after CD. The study involves exposing small uterine muscle tissue samples to various vasopressors—ephedrine, phenylephrine, and norepinephrine—alone or combined with oxytocin. Samples are bathed in physiological salt solution with increasing drug concentrations to observe contractility changes. These experiments will explore how these medications affect the muscle's contraction in diabetic versus healthy patients and analyze the receptors and pathways involved. Participants are pregnant women aged 19 to 45 undergoing elective cesarean delivery under spinal anesthesia, including those with Type II or gestational diabetes and healthy controls. After obtaining uterine tissue samples following delivery, researchers will measure contractility using motility index, amplitude, frequency, and area under the response curve over four hours. The study also monitors receptor expression and downstream pathways. Participation involves consenting to tissue sampling and data collection during standard CD procedures.
CONDITIONS
Brief 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, or healthy controls with no previous diagnosis
- Patients aged 19 to 45 years
- Patients with normal BMI (18-30) 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 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 or receiving oxytocin for induction of labor
- Emergency cesarean delivery in 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, except morbid obesity and macrosomia are allowed in diabetic group
- For healthy controls, BMI greater than 30 or less than 18
- Maternal age over 45 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day during cesarean delivery
Participants undergo cesarean delivery under spinal anesthesia. Myometrial tissue samples are collected during the procedure and exposed in vitro to different vasopressors and oxytocin to study contractility.
1 visit (in-person) at time of cesarean delivery
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
M
Mrinalini Balki, MD
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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