[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476785":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":68,"collaborators":70,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxytocin PK\u002FPD Arm","EXPERIMENTAL","Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after placental delivery.",[13],"Drug: deuterated oxytocin (d5OT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","deuterated oxytocin (d5OT)","Subjects will receive a 1 IU bolus of deuterated oxytocin (d5OT) intraoperatively during their nonemergent cesarean delivery.",[9],[21],"Deuterium-labeled oxytocin",[23],{"name":24,"affiliation":5,"role":25},"Naida M Cole, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","773-702-6700",null,"nmcole@bsd.uchicago.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Somayeh Mohammadi","17738343274","mohammadis@bsd.uchicago.edu",[37,55],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Stanford University","NOT_YET_RECRUITING","Stanford","California","94305","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.16608,37.42411,{"lat":49,"lon":48},[52],{"name":53,"role":28,"phone":54,"phoneExt":30,"email":30},"Brendan Carvalho, MD","650-723-6415",{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"RECRUITING","Chicago","Illinois","60637",{"type":46,"coordinates":61},[62,63],-87.65005,41.85003,{"lat":63,"lon":62},[66,67],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},{"type":69,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[71],{"name":38,"class":6},"100476785","phase-2-oxytocin-pharmacokinetics-and-pharmacodynamics-100476785",false,"NCT05488457","Oxytocin Pharmacokinetics and Pharmacodynamics","Pharmacokinetics and Pharmacodynamics of Oxytocin in Cesarean Delivery","Inclusion Criteria\n\n* 18-50 years old\n* intrauterine pregnancy\n* term (\\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy\n* non-emergent (scheduled or unscheduled) cesarean delivery\n\nExclusion Criteria:\n\n* allergy or contraindication to oxytocin\n* inability to provide informed consent","FEMALE","18 Years","50 Years",{"count":83,"type":84},100,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.\n\nAfter delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.\n\nThe goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.",[90,91,92],"Post Partum Hemorrhage","Cesarean Section Complications","Blood Loss",[94,95,96,97,98,99],"Oxytocin","pharmacokinetics and Pharmacodynamics","Uterine Tone","Postpartum","Elective C-Section","Parturients","2025-10-01",{"date":102,"type":103},"2025-10-03","ACTUAL",{"date":105,"type":103},"2025-01-01",{"date":107,"type":84},"2027-12-31",{"name":5,"class":6},2]