[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639514":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":75,"collaborators":27,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":27,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":27,"enrollmentInfo":86,"targetDuration":27,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,16],{"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",[13,14,15],"Drug: Azithromycin Prophylaxis","Drug: Cefazolin","Drug: Progesterone",{"label":17,"type":18,"description":11,"interventionNames":19},"Cerclage Without Azithromycin Prophylaxis","ACTIVE_COMPARATOR",[20,14,15],"Drug: Azithromycin Placebo",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Azithromycin Prophylaxis","500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Azithromycin Placebo","normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area",[17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"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.",[17,9],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Progesterone","progesterone 200 mg nightly after cerclage placement until 36 weeks gestation",[17,9],[41],{"name":42,"affiliation":43,"role":44},"Rachel Harrison, MD","advocate christ medical center","PRINCIPAL_INVESTIGATOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":27,"email":49},"CONTACT","616-218-2892","rachel.harrison@aah.org",[51,66],{"facility":52,"status":27,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Advocate Christ Medical Center","Oak Lawn","Illinois","60453","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-87.75811,41.71087,{"lat":62,"lon":61},[65],{"name":42,"role":47,"phone":48,"phoneExt":27,"email":49},{"facility":67,"status":27,"city":68,"state":54,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":27},"Advocate Lutheran General Hospital","Park Ridge","60068",{"type":59,"coordinates":71},[72,73],-87.84062,42.01114,{"lat":73,"lon":72},{"type":76,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"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":87,"type":88},80,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.",[94],"Cervical Insufficiency",[96,97,98],"short cervix","pregnancy prolongation","cerclage","NOT_YET_RECRUITING","2026-07-21",{"date":102,"type":103},"2026-07-23","ACTUAL",{"date":105,"type":88},"2026-08",{"date":107,"type":88},"2028-12",{"name":5,"class":6},2]