Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06285409

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

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

32

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered. This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further.

CONDITIONS

Official 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 to participate
  • Patients who require general anesthesia
  • Patients in labor or receiving oxytocin for induction of labor
  • Emergency cesarean delivery
  • Placenta accreta spectrum disorder
  • Patients who have had previous uterine surgery or more than one previous cesarean delivery
  • Patients with conditions predisposing to uterine atony and postpartum hemorrhage such as BMI over 40 kg/m2
  • Patients on medications affecting myometrial contractility, including insulin, nifedipine, labetalol, or magnesium sulphate

AI-Screening

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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

CONTACT

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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