Comparing uterotonic drugs to prevent postpartum bleeding after cesarean delivery
Official title: Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT06285409 · Data updated 2026-11-12
This study tests if giving extra doses of carbetocin or trying other medications can help women who have had a cesarean delivery prevent heavy bleeding by improving how well their uterus contracts.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 32 (estimated) |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | April 4, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06285409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are non-laboring women with a gestational age of 37-41 weeks undergoing elective cesarean delivery.
✕Probably not a fit
Patients who are in labor, require general anesthesia, or have conditions predisposing them to uterine atony may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of various uterotonic medications in enhancing uterine contractions after the administration of carbetocin, a drug commonly used to prevent postpartum hemorrhage. By analyzing small samples of uterine tissue taken from women undergoing cesarean sections, the study aims to determine if re-dosing with carbetocin or using alternative drugs like oxytocin, ergometrine, or carboprost can improve uterine contractility. The research focuses on addressing the issue of uterine atony, which can lead to excessive bleeding after childbirth. The findings could provide insights into optimizing treatment protocols for postpartum hemorrhage.
Why it matters
Potential benefit: If successful, this study could lead to improved management of postpartum hemorrhage, reducing maternal morbidity and mortality.
How similar studies have gone: While the use of uterotonics is well-established, this specific approach of comparing re-dosing strategies is novel and has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * 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 CD * Patients undergoing CD under spinal anesthesia Exclusion criteria * Patient refusal * Patients who require general anesthesia * Patients in labour and those receiving oxytocin for induction of labour * Emergency CD * placenta accreta spectrum disorder * Patients who have had previous uterine surgery or \>1 previous CD * Patients with any condition predisposing to uterine atony and PPH (BMI \> 40 kg/m2, * Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetalol or magnesium sulphate.
Where it's running
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Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
- Study coordinator: Mrinalini Balki, MD
- Email: mrinalini.balki@uhn.ca
- Phone: 416-586-4800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Carbetocin Alone vs Carbetocin Plus Oxytocin After Elective Cesarean Delivery
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This trial tests whether a single dose of carbetocin given after the second twin is born reduces heavy bleeding compared with standard oxytocin in people delivering twins.
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Draining the umbilical cord after birth to lower postpartum bleeding
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.