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

NCT06285396 | Suspended

• 1 other identifier: 24-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

oxytocin; type II diabetes; gestational diabetes; uterine contraction

Outcome Measures

Primary Outcomes (1)

• Motility index

  Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.

  4 hours

Secondary Outcomes (3)

• Amplitude of contraction

  4 hours

• Frequency of contraction

  4 hours

• Integrated area under response curve (AUC)

  4 hours

Study Arms (8)

Control

NO INTERVENTION

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

Ephedrine

ACTIVE COMPARATOR

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

Drug: Ephedrine

Phenylephrine

ACTIVE COMPARATOR

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

Drug: Phenylephrine

Norepinephrine

ACTIVE COMPARATOR

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

Drug: Norepinephrine

Control + oxytocin

ACTIVE COMPARATOR

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

Drug: Oxytocin

Ephedrine + oxytocin

ACTIVE COMPARATOR

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

Drug: Ephedrine; Drug: Oxytocin

Phenylephrine + oxytocin

ACTIVE COMPARATOR

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

Drug: Phenylephrine; Drug: Oxytocin

Norepinephrine + oxytocin

ACTIVE COMPARATOR

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

Drug: Norepinephrine; Drug: Oxytocin

Interventions

Ephedrine DRUG

Ephedrine in solution, at applicable concentrations based on literature.

Ephedrine; Ephedrine + oxytocin

Phenylephrine DRUG

Phenylephrine, at applicable concentrations based on literature.

Phenylephrine; Phenylephrine + oxytocin

Norepinephrine DRUG

Norepinephrine, at applicable concentrations based on literature.

Norepinephrine; Norepinephrine + oxytocin

Oxytocin DRUG

Oxytocin, at applicable concentrations based on literature.

Also known as: pitocin

Control + oxytocin; Ephedrine + oxytocin; Norepinephrine + oxytocin; Phenylephrine + oxytocin

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have given consent to participate in the study
• Patients with gestational age 37-41 weeks
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Diabetes Mellitus, Type 2; Diabetes, Gestational

Interventions

Ephedrine; Phenylephrine; Norepinephrine; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)