Recruiting

Ephedrine, Phenylepinephrine, Norepinephrine

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06285396

Conditions

Postpartum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Accepted

Interventions

Ephedrine

Phenylephrine

Norepinephrine

Oxytocin

Study Details

Brief 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.

Conditions

Postpartum Hemorrhage

Study ID

NCT06285396

Start date

Mar 18, 2024

Status verified date

Jul, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 caesarean delivery in 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.
  • For the healthy control group only, a BMI >30 or <18
  • Maternal age >45

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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..

Interventions

Ephedrine

Ephedrine in solution, at applicable concentrations based on literature.

Phenylephrine

Phenylephrine, at applicable concentrations based on literature.

Norepinephrine

Norepinephrine, at applicable concentrations based on literature.

Oxytocin

Oxytocin, at applicable concentrations based on literature.

Primary outcome measure

  • Motility index [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Apr 6, 2026

Last verified

Jul, 2025

Keywords

  • oxytocin
  • type II diabetes
  • gestational diabetes
  • uterine contraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-04-06.