Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06285409

Comparing Dose-response Profiles of Uterotonics After Initial Carbetocin Administration in Human Uterine Tissue

Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-06

32

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how different uterotonic drugs affect the contraction of the uterus after a cesarean delivery, especially when the first dose of carbetocin has been given. Uterine contraction is crucial to prevent postpartum hemorrhage caused by uterine atony, a condition where the uterus does not contract properly leading to excessive bleeding. This study aims to find which uterotonic drug—oxytocin, carbetocin, ergometrine, or carboprost—is most effective at enhancing uterine contraction after initial carbetocin use by testing tissue samples taken from the uterus. The study uses small samples of uterine muscle tissue collected from the incision site during cesarean section and exposes these samples to carbetocin followed by other uterotonic drugs. Researchers will test increasing doses of carbetocin, oxytocin, ergometrine, and carboprost in the laboratory to see how each affects uterine contraction. A control group with no drug added will also be included. This ex-vivo testing helps compare the effects of these drugs on tissue that has been previously treated with carbetocin. Participants are women undergoing elective cesarean delivery between 37 and 41 weeks of gestation who have not been exposed to oxytocin during labor. Tissue samples will be collected during surgery, and contractions will be measured by motility index, contraction amplitude, frequency, and response curves over four hours. The study will evaluate how well second doses of uterotonics improve contraction in desensitized uterine tissue. Safety monitoring and follow-up are managed within the surgical setting, and the study is expected to complete by December 2026.

CONDITIONS

Brief Title

Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who give written consent to participate in this study
  • Patients with gestational age 37-41 weeks
  • Non-laboring patients, not exposed to exogenous oxytocin
  • Patients requiring elective primary or first repeat cesarean delivery
  • Patients undergoing cesarean delivery under spinal anesthesia
Not Eligible

You will not qualify if you...

  • Patient refusal
  • Patients who require general anesthesia
  • Patients in labor or receiving oxytocin for labor induction
  • Emergency cesarean delivery
  • Placenta accreta spectrum disorder
  • Patients with previous uterine surgery or more than one previous cesarean delivery
  • Patients with conditions predisposing to uterine atony and postpartum hemorrhage (BMI over 40 kg/m2)
  • Patients on medications affecting uterine contractions such as insulin, nifedipine, labetalol, or magnesium sulphate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 4 hours

Participants' uterine tissue samples are exposed to a first dose of carbetocin followed by dose-response testing with increasing concentrations of one of the study drugs (carbetocin, oxytocin, ergometrine, or carboprost) or placebo in an ex-vivo setting to evaluate myometrial contractions.

1 visit (ex-vivo tissue testing)

Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G1X5

Actively Recruiting

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Research Team

M

Mrinalini Balki, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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