protocolSection identificationModule nctId: NCT06285409, orgStudyIdInfo id: 24-02, briefTitle: Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Carbetocin, interventions name: Oxytocin, interventions name: Carbetocin, interventions name: Oxytocin, interventions name: Ergonovine, interventions name: Carboprost, outcomesModule primaryOutcomes measure: Motility index, secondaryOutcomes measure: Amplitude of contraction, secondaryOutcomes measure: Frequency of contraction, secondaryOutcomes measure: Integrated area under response curve (AUC), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Mrinalini Balki, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: mrinalini.balki@uhn.ca, contacts name: Wafa Bellan, MD, role: SUB_INVESTIGATOR, contacts name: Ronald George, MD, role: SUB_INVESTIGATOR, contacts name: Joseph Park, BSc, role: SUB_INVESTIGATOR, contacts name: Anuradha Baishnob, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False