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

RecruitingNAAges 18 Years - 45 YearsFemaleSamuel Lunenfeld Research Institute, Mount Sinai …
NCT06285409 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tis

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📋 Eligibility rules (as published)
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.
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What it tests

  • Carbetocin
  • Oxytocin
  • Carbetocin
  • Oxytocin
  • Ergonovine
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Where

1 site
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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