[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646809":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":24,"responsibleParty":39,"collaborators":24,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":24,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":67,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":24},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxytocin Bolus","ACTIVE_COMPARATOR","Patients in the bolus arm will receive a 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby\u002Futerine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml\u002Fhr. If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 3 IU oxytocin is given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU\u002Fhr is started at 100ml\u002Fhrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and\u002F or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml\u002Fhr for a total of 1 hour, then changed to 38 ml\u002F hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU\u002Fhr (100ml\u002Fhr) is started and maintained",[13],"Drug: Oxytocin Bolus or Oxytocin Infusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Oxytocin Infusion","Patients in the infusion arm will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby\u002Futerine cord clamping and a maintenance infusion of 18 IU\u002Fhr Oxytocin IV (225ml\u002Fhr). If uterine tone is considered inadequate after an additional 3 minutes, a second bolus of 0.9% Saline will be given IV over 15 seconds. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 0.9% Saline will be given IV over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion of 0.9% Saline will be started at 100 ml\u002Fhr for 4 hours, second line uterotonic agents (Methergine, Hemabate and\u002For Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU\u002Fhour (450 ml\u002Fhr) for a total of 1 hour, and then changed to 38 ml\u002Fhr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml\u002Fhr will be started and maintained for 4 hours.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Oxytocin Bolus or Oxytocin Infusion","On the day of surgery, patients will be randomized to receive either bolus or infusion administration of Oxytocin.\n\nOn the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Tiffany E Angelo, DO, FASA","Stony Brook University Hospital Department of Anesthesiology","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","631-759-0328","tiffany.angelo@stonybrookmedicine.edu",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Anna E Suske","631-317-8420","anna.suske@stonybrookmedicine.edu",{"type":29,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Tiffany E. Angelo, D.O.","Principal Investigator","100646809","phase-4-oxytocin-bolus-versus-infusion-in-high-risk-patients-undergoing-elective-cesarean-section-inbox-hr-100646809",false,"NCT07688512","Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)","Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section","INBOX-HR","Inclusion Criteria:\n\n* Undergoing elective cesarean section under spinal anesthesia or combined spinal anesthesia (CSE)\n* Patients must be able to provide written informed consent in either English or Spanish\n* Parturient classified as high risk for postpartum hemorrhage as defined by the adapted California Maternal Quality Care Obstetric Hemorrhage Risk Screen\n\nExclusion Criteria:\n\n* Parturient in labor or ruptured membranes\n* Patient does not possess the physical and mental capacity to provide informed consent\n* Urgent or emergent cesarean sections\n* Patients with a known major coagulopathy\n* Patients with significant thrombocytopenia limiting neuraxial anesthesia (\\\u003C70k)\n* Patients on therapeutic anticoagulation at time of procedure\n* Patients on the placenta accreta spectrum\n* Patients with severe cardiac disease contraindicating oxytocin\n* Patients with an allergy to oxytocin","FEMALE","18 Years","45 Years",{"count":54,"type":55},180,"ESTIMATED","INTERVENTIONAL",[58],"PHASE4","The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are:\n\n1. Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter?\n2. Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion?\n3. Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections?\n\n3\\. Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion?\n\nResearchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective.\n\nParticipants will:\n\n1. Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born.\n2. Be asked a question about their experience 2 hours after the surgery.\n3. Allow the research team to collect information about how they are doing from their hospital medical records.",[61,62,63,64],"Postpartum Hemorrhage","Uterine Atony","Uterine Atony With Hemorrhage","Elective Cesarean Section",[66],"Oxytocin bolus vs infusion in elective cesarean section in patients at high risk for postpartum hemorrhage","NOT_YET_RECRUITING","2026-07-30",{"date":70,"type":71},"2026-08-03","ACTUAL",{"date":73,"type":55},"2026-08",{"date":75,"type":55},"2029-02",{"name":5,"class":6}]