[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643446":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":76,"collaborators":51,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":51,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":110,"whyStopped":51,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group C - Carbetocin Monotherapy","ACTIVE_COMPARATOR","Carbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by placebo infusion (500 mL 0.9% sodium chloride at 83 mL\u002Fhour over 4 hours). The infusion bag is visually identical to the active arm.",[13,14],"Drug: Carbetocin","Drug: Placebo Saline Infusion",{"label":16,"type":17,"description":18,"interventionNames":19},"Group C+O - Carbetocin Plus Oxytocin","EXPERIMENTAL","Carbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by active infusion (oxytocin 10 IU in 500 mL 0.9% sodium chloride at 83 mL\u002Fhour over 4 hours).",[13,20],"Drug: Oxytocin",[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Carbetocin","Carbetocin 100 micrograms (1 mL) IV bolus administered over 1 minute immediately after umbilical cord clamping. Identical administration in both arms.",[9,16],[28,29],"Duratocin","Pabal",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Oxytocin","Oxytocin 10 IU added to 500 mL 0.9% sodium chloride, infused at 83 mL\u002Fhour over 4 hours, initiated within 2 minutes of carbetocin bolus. Administered in the combination arm only.",[16],[35],"Syntocinon",{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo Saline Infusion","500 mL 0.9% sodium chloride infused at 83 mL\u002Fhour over 4 hours, initiated within 2 minutes of carbetocin bolus. Visually identical to the active oxytocin infusion. Administered in the monotherapy arm only.",[9],[41],"Normal Saline Placebo",[43],{"name":44,"affiliation":45,"role":46},"Mohamed A Tolba, MD","Qassim University Medical City","PRINCIPAL_INVESTIGATOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","966507439018",null,"m_atolba1234@mans.edu.eg",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Omar S Al Misnid, MD9","966561205555","OMisnid@qumc.edu.sa",[58],{"facility":45,"status":51,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Buraidah","Al-Qassim Region","51452","Saudi Arabia","SA",{"type":65,"coordinates":66},"Point",[67,68],43.97497,26.32599,{"lat":68,"lon":67},[71,72,74],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},{"name":73,"role":49,"phone":55,"phoneExt":51,"email":56},"Omar S Al Misnid, MD",{"name":75,"role":46,"phone":51,"phoneExt":51,"email":51},"Omar Saleh Al Misnid, MD",{"type":46,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Mohamed Ahmed Tolba","Consultant Anesthesiologist","100643446","phase-4-carbetocin-monotherapy-versus-carbetocin-plus-oxytocin-infusion-in-elective-cesarean-delivery-a-non-inferiority-trial-100643446",false,"NCT07636421","Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial","Comparative Efficacy of Carbetocin Monotherapy Versus Carbetocin With Supplemental Oxytocin Infusion in Maintaining Uterine Tone and Preventing Blood Loss in Elective Cesarean Delivery: A Randomized, Double-Blind, Non-Inferiority Controlled Trial","CARBOXY-RCT","Inclusion Criteria:\n\n* Adult women aged 18 to 45 years\n* Scheduled for elective non-emergency cesarean delivery\n* Spinal anesthesia planned and administered as the sole anesthetic technique\n* Singleton pregnancy at gestational age of 37 completed weeks or more\n* ASA physical status II\n* Preoperative hemoglobin of 9 g\u002FdL or more\n* Able to provide written informed consent in Arabic or English\n\nExclusion Criteria:\n\n* Emergency or crash cesarean delivery\n* Placenta previa, placenta accreta spectrum disorder, or other abnormal placentation\n* Known uterine anomalies likely to impair contractility including fibroids greater than 5 cm, bicornuate or unicornuate uterus\n* Grand multiparity defined as 5 or more previous deliveries\n* Multiple gestation including twins or higher order\n* Polyhydramnios defined as amniotic fluid index greater than 24 cm\n* Prior oxytocin augmentation in current pregnancy for more than 6 hours\n* Known hypersensitivity to carbetocin, oxytocin, or any formulation excipient\n* Severe preeclampsia, eclampsia, or HELLP syndrome\n* Cardiovascular disease including arrhythmia, valvular disease, cardiomyopathy, or ischemic heart disease\n* Known coagulopathy or thrombocytopenia with platelets less than 100 x 10\\^9\u002FL\n* Hepatic or renal impairment\n* Body mass index greater than 40 kg\u002Fm2 at time of delivery\n* Enrollment in another interventional clinical trial","FEMALE","18 Years","45 Years",{"count":91,"type":92},332,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Concurrent oxytocin receptor stimulation may be redundant, counterproductive through receptor desensitization, or incrementally beneficial - a mechanistic uncertainty that remains unresolved in the published literature.\n\nObjectives: To determine whether carbetocin monotherapy (100 micrograms IV bolus plus placebo infusion) is non-inferior to carbetocin plus supplemental oxytocin infusion (10 IU over 4 hours) in preventing the need for additional uterotonic agents within 24 hours of elective cesarean delivery.\n\nStudy Design: Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial with an integrated pilot phase. Phase 1 (Pilot, n=60) establishes local feasibility and event rate. Phase 2 (Full trial, n=332) provides the definitive non-inferiority analysis.\n\nParticipants: Women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Qassim University Medical City, singleton pregnancy at or beyond 37 weeks, ASA physical status II, preoperative hemoglobin 9 g\u002FdL or more.\n\nInterventions: Group C (Monotherapy): Carbetocin 100 micrograms IV bolus plus placebo saline infusion 500 mL over 4 hours. Group C+O (Combination): Carbetocin 100 micrograms IV bolus plus oxytocin 10 IU in 500 mL saline over 4 hours.\n\nPrimary Outcome: Proportion of patients requiring at least one additional uterotonic agent within 24 hours of delivery.\n\nSecondary Outcomes: Quantitative intraoperative blood loss by gravimetric measurement; total 24-hour blood loss; actual blood loss by Gross formula; hemoglobin and hematocrit changes; uterine tone scores by verbal numerical rating scale (0-10) at 2, 5, and 10 minutes; incidence of postpartum hemorrhage; blood transfusion requirement; hemodynamic profiles; adverse effects.\n\nSample Size: 332 patients (166 per group), non-inferiority margin 10 percentage points, one-sided alpha 0.025, 80% power, estimated baseline event rate 10%, with 15% dropout allowance.",[98,99,100,101],"Postpartum Hemorrhage","Uterine Atony","Cesarean Section","Blood Loss, Surgical",[24,31,103,104,105,106,107,108,109],"Uterotonic","Elective Cesarean Delivery","Non-Inferiority Trial","Uterine Tone","Gravimetric Blood Loss","Obstetric Anesthesia","Spinal Anesthesia","NOT_YET_RECRUITING","2026-06-04",{"date":113,"type":114},"2026-06-09","ACTUAL",{"date":116,"type":92},"2026-08",{"date":118,"type":92},"2028-08",{"name":5,"class":6},1]