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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Mrinalini Balki, MD
mrinalini.balki@uhn.ca
416-586-4800
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 96
Treatments
No_intervention: Control
The myometrial samples are bathed in physiological salt solution (PSS) only.
Active_comparator: Ephedrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine.
Active_comparator: Phenylephrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine.
Active_comparator: Norepinephrine
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine.
Active_comparator: Control + oxytocin
The myometrial samples are bathed in physiological salt solution (PSS) and oxytocin.
Active_comparator: Ephedrine + oxytocin
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine and oxytocin..
Active_comparator: Phenylephrine + oxytocin
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine and oxytocin..
Active_comparator: Norepinephrine + oxytocin
The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine and oxytocin..
Sponsors
Leads: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

This content was sourced from clinicaltrials.gov