Ephedrine, Phenylephrine, and Norepinephrine for Gestational Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for pregnant individuals with Type II or gestational diabetes who are undergoing an elective Cesarean delivery. They must be willing to provide uterine tissue samples during the procedure. There's no specific exclusion criteria provided, but typically those with conditions that may interfere with study results or pose a risk would not qualify.

Inclusion Criteria

Patients who have given consent to participate in the study

I am between 19 and 40 years old.

Patients requiring elective primary or first repeat caesarean delivery

Exclusion Criteria

I need general anesthesia for my treatment.

I am over 45 years old.

Emergency caesarean delivery in labor

Treatment Details

Interventions

• Ephedrine (Vasopressor)
• Norepinephrine (Vasopressor)
• Phenylephrine (Vasopressor)

Trial Overview The study investigates how different vasopressors—Ephedrine, Phenylephrine, and Norepinephrine—affect the contraction of uterine muscles when given after childbirth to manage low blood pressure caused by spinal anesthesia in diabetic patients.

Participant Groups

Group I: Control Active Control 1 Intervention

The myometrial samples are bathed in physiological salt solution (PSS) only.

Group II: Phenylephrine + oxytocin Active Control 2 Interventions

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine and oxytocin..

Group III: Ephedrine Active Control 1 Intervention

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine.

Group IV: Phenylephrine Active Control 1 Intervention

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of phenylephrine.

Group V: Norepinephrine Active Control 1 Intervention

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine.

Group VI: Control + oxytocin Active Control 1 Intervention

The myometrial samples are bathed in physiological salt solution (PSS) and oxytocin.

Group VII: Ephedrine + oxytocin Active Control 2 Interventions

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of ephedrine and oxytocin..

Group VIII: Norepinephrine + oxytocin Active Control 2 Interventions

The myometrial samples are bathed in physiological salt solution (PSS) with increasing concentrations of norepinephrine and oxytocin..

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mount Sinai Hospital Toronto, Canada

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+

Dr. Anne-Claude Gingras

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Chief Executive Officer

PhD in Functional Proteomics, Canada Research Chair

Dr. Susanna Mak

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Chief Medical Officer since 2004

MD, University of Toronto