[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458100":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":54,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Oxytocin only","ACTIVE_COMPARATOR","Patients will receive standard postpartum Oxytocin IV per protocol",[13],"Drug: IV Oxytocin",{"label":15,"type":16,"description":17,"interventionNames":18},"Misoprostol plus intravenous Oxytocin","EXPERIMENTAL","Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual",[19,13],"Drug: Sublingual Misoprostol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sublingual Misoprostol","Misoprostol 400 mcg sublingual",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"IV Oxytocin","40 units IV Oxytocin in 1000 mL normal saline",[9,15],[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Stony Brook","New York","11794","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-73.14094,40.92565,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Erin Cassella","CONTACT","631-444-7650","erin.casella@stonybrookmedicine.edu",{"name":52,"role":53,"phone":26,"phoneExt":26,"email":26},"James Bernasko, MD","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"James Bernasko","MD, Professor, Clinical Obstetrics, Principal investigator","100458100","phase-3-double-simultaneous-uterotonic-agents-versus-single-agent-regimen-to-prevent-early-postpartum-hemorrhage-100458100",false,"NCT05245227","Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage","A Randomized Controlled Trial of Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage","Inclusion Criteria:\n\n\\- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study\n\nExclusion Criteria:\n\n* Women under 18 years old\n* Women with known coagulation disorders\n* Women with planned cesarean hysterectomy\n* Women with known placental accreta spectrum disorders\n* Women with known allergy to prostaglandins",true,"FEMALE","18 Years",{"count":68,"type":69},1358,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.\n\nThere have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.\n\nSpecific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.\n\nSpecific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).",[75],"Postpartum Hemorrhage","2025-04-30",{"date":78,"type":79},"2025-05-04","ACTUAL",{"date":81,"type":79},"2025-01-27",{"date":83,"type":69},"2027-01-01",{"name":5,"class":6},1]