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

Postpartum Hemorrhage

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.

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Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 to 45

Participation 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.

Study Location

Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Mrinalini Balki, MD

[email protected]
416-586-4800
Study Sponsored By
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Participants Required
More Information
Study ID: NCT06285409