[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562588":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":51,"locations":59,"responsibleParty":297,"collaborators":299,"id":304,"slug":305,"hasResults":306,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":312,"sex":313,"minAge":27,"maxAge":27,"enrollmentInfo":314,"targetDuration":27,"studyType":317,"phases":318,"briefSummary":320,"conditions":321,"keywords":325,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},{"fullName":5,"class":6},"The George Washington University Biostatistics Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Azithromycin prophylaxis and standard of care preoperative antibiotics","EXPERIMENTAL","500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.",[13,14],"Drug: Azithromycin Injection","Drug: Standard of Care Preoperative antibiotics",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo and standard of care preoperative antibiotics","PLACEBO_COMPARATOR","Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.",[20,14],"Drug: Placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Azithromycin Injection","500mg azithromycin in 250 mL of normal saline",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo","250 mL of normal saline",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Standard of Care Preoperative antibiotics","standard of care preoperative antibiotics (excluding azithromycin) prior to incision",[9,16],[37,41,44,48],{"name":38,"affiliation":39,"role":40},"Alan T.N. Tita, MD PhD","University of Alabama at Birmingham","STUDY_CHAIR",{"name":42,"affiliation":43,"role":40},"Kim Boggess, MD","University of North Carolina, Chapel Hill",{"name":45,"affiliation":46,"role":47},"Monica Longo, MD PhD","Eunice Kennedy Shriver NICHD","STUDY_DIRECTOR",{"name":49,"affiliation":5,"role":50},"Rebecca G Clifton, PhD","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":27,"email":55},"CONTACT","301-881-9260","rclifton@bsc.gwu.edu",{"name":57,"role":53,"phone":27,"phoneExt":27,"email":58},"Steven Weiner, MS","weiner@bsc.gwu.edu",[60,81,98,114,130,147,163,180,196,213,229,247,268,280],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"University of Alabama - Birmingham","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-86.80249,33.52066,{"lat":72,"lon":71},[75,79],{"name":76,"role":53,"phone":77,"phoneExt":27,"email":78},"Nancy Saxon, RN","205-934-1616","nbsaxon@uabmc.edu",{"name":80,"role":50,"phone":27,"phoneExt":27,"email":27},"Alan TN Tita, MD",{"facility":82,"status":62,"city":83,"state":84,"zip":85,"country":66,"countryCode":67,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Regents of the University of California San Francisco","San Francisco","California","94143",{"type":69,"coordinates":87},[88,89],-122.41942,37.77493,{"lat":89,"lon":88},[92,96],{"name":93,"role":53,"phone":94,"phoneExt":27,"email":95},"Natalie Oman, MPH","206-718-4703","natalie.oman@ucsf.edu",{"name":97,"role":50,"phone":27,"phoneExt":27,"email":27},"Mary Norton, MD",{"facility":99,"status":62,"city":100,"state":101,"zip":102,"country":66,"countryCode":67,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Northwestern University","Chicago","Illinois","60611",{"type":69,"coordinates":104},[105,106],-87.65005,41.85003,{"lat":106,"lon":105},[109,112],{"name":110,"role":53,"phone":27,"phoneExt":27,"email":111},"Elizabeth Rangel, RN","elizabeth.rangel@northwestern.edu",{"name":113,"role":50,"phone":27,"phoneExt":27,"email":27},"Lynn Yee, MD",{"facility":115,"status":62,"city":116,"state":116,"zip":117,"country":66,"countryCode":67,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Columbia University","New York","10032",{"type":69,"coordinates":119},[120,121],-74.00597,40.71427,{"lat":121,"lon":120},[124,128],{"name":125,"role":53,"phone":126,"phoneExt":27,"email":127},"Megan Loffredo, MD, CCRC","203-722-1058","ml4639@cumc.columbia.edu",{"name":129,"role":50,"phone":27,"phoneExt":27,"email":27},"Noelia Zork, MD",{"facility":131,"status":62,"city":132,"state":133,"zip":134,"country":66,"countryCode":67,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"University of North Carolina - 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Houston",{"type":69,"coordinates":271},[254,255],{"lat":255,"lon":254},[274,278],{"name":275,"role":53,"phone":276,"phoneExt":27,"email":277},"Felecia Ortiz, RN","713-500-6467","felecia.ortiz@uth.tmc.edu",{"name":279,"role":50,"phone":27,"phoneExt":27,"email":27},"Hector Mendez-Figueroa, MD",{"facility":281,"status":62,"city":282,"state":283,"zip":284,"country":66,"countryCode":67,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"University of Utah","Salt Lake City","Utah","84132",{"type":69,"coordinates":286},[287,288],-111.89105,40.76078,{"lat":288,"lon":287},[291,295],{"name":292,"role":53,"phone":293,"phoneExt":27,"email":294},"Amber Sowles, RN","801-585-5499","amber.sowles@hsc.utah.edu",{"name":296,"role":50,"phone":27,"phoneExt":27,"email":27},"Torri Metz, MD",{"type":298,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[300,303],{"name":301,"class":302},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":39,"class":6},"100562588","phase-3-azithromycin-prophylaxis-for-prelabor-cesarean-delivery-trial-100562588",false,"NCT06605118","Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial","Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial","PRECEDE","Inclusion Criteria:\n\n* ≥ 23 weeks' gestation (ACOG dating criteria)\n* Scheduled or prelabor cesarean delivery\n* Singleton or twin gestation\n\nExclusion Criteria:\n\n* Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice\u002Fhepatic dysfunction associated with prior use of azithromycin\n* Chorioamnionitis\n* Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery\n* Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)\n* Fetal demise or known major congenital anomaly\n* Azithromycin treatment within 7 days\n* Planned use of antimicrobial prophylaxis after delivery for any reason\n* Known structural heart disease or active cardiomyopathy (current ejection fraction\\\u003C40%)\n* Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin\n* Refusal or unable to obtain consent (e.g., language barrier)\n* Participating in another intervention study that influences the primary outcome in this study\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.",true,"FEMALE",{"count":315,"type":316},8000,"ESTIMATED","INTERVENTIONAL",[319],"PHASE3","This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.",[322,323,324],"Obstetrical Complications","Labor and Delivery Complication","Cesarean Delivery",[326,327,328,329,330],"cesarean delivery","infection","maternal morbidity","antibiotics","prevention","2026-04-03",{"date":333,"type":334},"2026-04-09","ACTUAL",{"date":336,"type":334},"2024-11-06",{"date":338,"type":316},"2027-11-30",{"name":5,"class":6},14]