[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639514":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":70,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cerclage and Azithromycin Prophylaxis","EXPERIMENTAL","women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations",[13,14],"Drug: Azithromycin Prophylaxis","Drug: Cefazolin",{"label":16,"type":17,"description":11,"interventionNames":18},"Cerclage Without Azithromycin Prophylaxis","ACTIVE_COMPARATOR",[19,14],"Drug: Azithromycin Placebo",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azithromycin Prophylaxis","500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Azithromycin Placebo","normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area",[16],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Cefazolin","All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.",[16,9],[36],{"name":37,"affiliation":38,"role":39},"Rachel Harrison, MD","advocate christ medical center","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","616-218-2892","rachel.harrison@aah.org",[46,61],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Advocate Christ Medical Center","Oak Lawn","Illinois","60453","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-87.75811,41.71087,{"lat":57,"lon":56},[60],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},{"facility":62,"status":26,"city":63,"state":49,"zip":64,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":26},"Advocate Lutheran General Hospital","Park Ridge","60068",{"type":54,"coordinates":66},[67,68],-87.84062,42.01114,{"lat":68,"lon":67},{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100639514","phase-4-azithromycin-for-cerclage-prophylaxis-100639514",false,"NCT07608562","Azithromycin for Cerclage Prophylaxis","Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study","Inclusion Criteria:\n\n* Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment\n* Indication for transvaginal cerclage placement\n* Intact amniotic membranes\n\nExclusion Criteria:\n\n* Evidence of active infection or chorioamnionitis at presentation\n* Preterm prelabor rupture of membranes (PPROM)\n* Multiple gestation\n* HIV positive status\n* Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)\n* Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)\n* Major fetal anomaly or known chromosomal abnormalities that significantly affect viability\n* Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage","FEMALE","18 Years",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.",[89],"Cervical Insufficiency",[91,92,93],"short cervix","pregnancy prolongation","cerclage","NOT_YET_RECRUITING","2026-06-24",{"date":97,"type":98},"2026-06-25","ACTUAL",{"date":100,"type":83},"2026-08",{"date":102,"type":83},"2028-12",{"name":5,"class":6},2]