Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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