protocolSection identificationModule nctId: NCT06333340, orgStudyIdInfo id: 24-03, briefTitle: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors., conditionsModule conditions: Post Partum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin, interventions name: Carbetocin, outcomesModule primaryOutcomes measure: Proportion of parturients requiring additional uterotonic agents intraoperatively, secondaryOutcomes measure: Uterine Tone 3 minutes, secondaryOutcomes measure: Uterine Tone 5 minutes, secondaryOutcomes measure: Uterine Tone 10 minutes, secondaryOutcomes measure: Calculated blood loss (CBL), secondaryOutcomes measure: Semi-quantitative blood loss (SQBL), secondaryOutcomes measure: Presence of blood transfusion, secondaryOutcomes measure: Number of patients with ICU admission, secondaryOutcomes measure: Number of patients with conservative surgical methods to manage post partum hemorrhage, secondaryOutcomes measure: Number of patients with radiological methods used to manage post partum hemorrhage, secondaryOutcomes measure: Number of patients with surgical post partum hemorrhage management measures, secondaryOutcomes measure: Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline, secondaryOutcomes measure: Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline, secondaryOutcomes measure: Number of patients with tachycardia defined as heart rate greater than 130% of baseline, secondaryOutcomes measure: Number of patients with bradycardia defined as heart rate less than 70% of baseline, secondaryOutcomes measure: Presence of ventricular tachycardia: ECG, secondaryOutcomes measure: Presence of atrial fibrillation: ECG, secondaryOutcomes measure: Presence of atrial flutter: ECG, secondaryOutcomes measure: Presence of nausea: questionnaire, secondaryOutcomes measure: Presence of vomiting: questionnaire, secondaryOutcomes measure: Number of patients with chest pain: questionnaire, secondaryOutcomes measure: Number of patients with shortness of breath: questionnaire, secondaryOutcomes measure: Number of patients with headache: questionnaire, secondaryOutcomes measure: Number of patients with flushing: questionnaire, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, 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: Narinder Singh, MD, role: SUB_INVESTIGATOR, contacts name: Ronald George, MD, role: SUB_INVESTIGATOR, contacts name: Kristi Downey, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False