NCT06285409 Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
| NCT ID | NCT06285409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-04-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Mrinalini Balki, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT06285409 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285409 currently recruiting?
Yes, NCT06285409 is actively recruiting participants. Contact the research team at mrinalini.balki@uhn.ca for enrollment information.
Where is the NCT06285409 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06285409 clinical trial?
NCT06285409 is sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. The principal investigator is Mrinalini Balki, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 32 participants.