NCT06285396Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 18 Mar 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06285396
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 18 Mar 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients in labor and those receiving oxytocin for induction of 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.
Age
- Maternal age \>45
Other
- Patients who refuse to give written informed consent
- Patients who require general anesthesia
- Emergency caesarean delivery in labor
- For the healthy control group only, a BMI \>30 or \<18
Who the study is looking for
- 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
Age in the registry: 19 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.