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

Recruiting now · Not applicable

Conditions studied: Postpartum Hemorrhage

In brief

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.

Key facts

Study ID: NCT06285409
Run by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
People needed: 32
Starts: 2024-04-04
Expected to finish: 2026-12-01
Last updated by the study team: 2026-04-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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