[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-atony\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-atony":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,82,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"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":21,"type":22},332,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Postpartum Hemorrhage","Uterine Atony","Cesarean Section","Blood Loss, Surgical",[33,34,35,36,37,38,39,40,41],"Carbetocin","Oxytocin","Uterotonic","Elective Cesarean Delivery","Non-Inferiority Trial","Uterine Tone","Gravimetric Blood Loss","Obstetric Anesthesia","Spinal Anesthesia","NOT_YET_RECRUITING","2026-06-04",{"date":45,"type":46},"2026-06-09","ACTUAL",{"date":48,"type":22},"2026-08",{"date":50,"type":22},"2028-08",{"name":52,"class":53},"Mansoura University","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100638930","exteriorization-versus-in-situ-hysterotomy-repair-during-cesarean-effects-on-uterine-tone-100638930","NCT07606846","Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone","Uterine Exteriorization Versus In Situ Hysterectomy Repair During Cesarean Delivery: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-55\n* Undergoing cesarean section\n\nExclusion Criteria:\n\n* Patient age \\\u003C18 or \\>55\n* Case urgency deemed too great for consent","55 Years",{"count":64,"type":22},60,[66],"NA","During standard cesarean deliveries, there are two ways that obstetricians repair the incision on the uterus (hysterotomy after delivery of the baby. One method involves lifting the uterus out of its regular place in the abdomen to repair the incision (uterine exteriorization for repair). The second method involves leaving the uterus inside the abdomen to repair the uterus (in situ repair). Both of these methods are regularly used by obstetricians during cesarean deliveries, and it is not currently known if one has benefits over the other. Currently, surgeons use both methods, but lifting the uterus out of its place is slightly more common. In this study, participants will be randomly assigned to have one of these techniques performed during their surgery. Researchers will be investigating whether one technique or the other leads to better contraction of the uterus after delivery, less bleeding, less intra-operative nausea\u002Fvomiting, or a better patient experience than another.",[28,29,69,30],"Uterine Atony With Hemorrhage",[28,29,71,30,72,38],"Uterine Atony with Hemorrhage","Cesarean Delivery","2026-05-22",{"date":75,"type":46},"2026-05-27",{"date":77,"type":22},"2026-06-01",{"date":79,"type":22},"2029-06-01",{"name":81,"class":53},"Stanford University",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100640535","balloon-tamponade-versus-gauze-packing-for-postpartum-hemorrhage-100640535","NCT07609589","Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage","Comparison of Efficacy of Uterine Balloon Tamponade Versus Uterine Gauze Packing in Patients With Postpartum Hemorrhage With Uterine Atony","Inclusion Criteria:\n\n* Women aged 18 to 40 years\n* Gestational age between 37 and 42 weeks\n* Parity up to 4\n* Diagnosed with postpartum hemorrhage due to uterine atony\n\nExclusion Criteria:\n\n* Postpartum hemorrhage due to perineal, cervical, or vaginal trauma\n* Retained products of conception\n* Vaginal delivery after previous cesarean section\n* Known coagulation disorders\n* Sepsis","40 Years",{"count":91,"type":22},216,[66],"Postpartum hemorrhage due to uterine atony is a major cause of maternal morbidity and mortality. This randomized controlled trial aims to compare the efficacy of uterine balloon tamponade and uterine gauze packing in controlling bleeding in women with postpartum hemorrhage. A total of 216 participants will be randomly assigned to one of the two treatment groups. All patients will receive standard medical management including uterotonic agents prior to intervention. The primary outcome is cessation of uterine bleeding within 24 hours after the procedure. This study aims to identify a safe and effective method for managing postpartum hemorrhage in a resource-limited setting.",[28,29],[96,97,98,99],"postpartum hemorrhage","uterine atony","balloon tamponade","uterine packing","2026-05-21",{"date":75,"type":46},{"date":103,"type":22},"2026-07-01",{"date":105,"type":22},"2027-01-10",{"name":107,"class":53},"Khyber Teaching Hospital",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":54},"100609693","phase-2-prophylactic-intravenous-calcium-gluconate-to-decrease-blood-loss-at-time-of-cesarean-delivery-in-pregnant-patients-at-high-risk-for-uterine-atony-100609693","NCT07217899","Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony","Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony","Inclusion Criteria:\n\n* English speaking\n* Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks\n* Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery\n* Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:\n\n  1. \\> 4 Prior deliveries\n  2. General anesthesia\n  3. Multifetal gestation\n  4. Polyhydramnios diagnosed by ultrasound within 2 weeks\n  5. Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound\n  6. Fibroid uterus, defined as: Multiple ≥ 2cm intramural\n  7. Any history of prior Primary postpartum hemorrhage (PPH)\n  8. Platelets \\\u003C 100,000 (but \\>50,000\n  9. Placenta Previa\n  10. Body Mass Index (BMI) ≥ 40\n\nExclusion Criteria:\n\n* Non-English speaking\n* Antenatal suspicion for placenta accreta spectrum\n* History of allergic reaction to Calcium Gluconate\n* Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis\n* Underlying Renal Disease defined as Cr\\>1.0\n* Known underlying cardiac condition\n* Cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication\n* Treatment with a calcium channel blocker medication within 24 hours of screening\n* Hypertensive disorder necessitating intravenous antihypertensive medication within 24 hours of screening\n* Emergent case where study participation could impede care (judgement of obstetrician or anesthesiologist)\n* Known hypercalcemia\n* Concurrent use of any drugs that may cause hypercalcemia including\n\n  1. Vitamin D\n  2. Vitamin A\n  3. Thiazide Diuretics\n  4. Calcipotriene\n  5. Teriparatide\n* Ceftriaxone within 48 hours of screening\n* Total Parenteral Nutrition (TPN) within 48 hours of screening\n* Known Coagulopathy International Normalized Ratio (INR) ≥ 1.5\n* Vaginal delivery",{"count":116,"type":22},140,[118],"PHASE2","This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.",[31,121,29],"Blood Loss, Postoperative",[123],"Cesarean delivery","RECRUITING","2025-10-28",{"date":127,"type":46},"2025-10-29",{"date":129,"type":46},"2025-10-20",{"date":48,"type":22},{"name":132,"class":53},"University of Michigan"]