[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607046":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard antibiotic regimen (Ampicillin and Amoxicillin)","ACTIVE_COMPARATOR","Participants in the control arm receive the standard antibiotic regimen for late PPROM, consisting of intravenous Ampicillin 2g every 6 hours for 48 hours, followed by oral Amoxicillin 500mg every 8 hours for 5 days, administered according to current clinical guidelines",[13],"Drug: Ampicillin\u002FAmoxicillin plus single-dose PO Azithromycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention Arm - Standard Antibiotics with Azithromycin","EXPERIMENTAL","Participants in this arm will receive the standard antibiotic regimen of intravenous Ampicillin followed by oral Amoxicillin, plus a single dose of 1 gram oral Azithromycin",[19],"Drug: Intravenous Ampicillin followed by Oral Amoxicillin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravenous Ampicillin followed by Oral Amoxicillin","This intervention consists of intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ampicillin\u002FAmoxicillin plus single-dose PO Azithromycin","This intervention includes intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days, plus a single dose of oral Azithromycin 1 gram administered once at the start of treatment",[9],[32],{"name":33,"affiliation":5,"role":34},"Noa Gonen, MD","STUDY_CHAIR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","972-54-3955584","gonen.noa7@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Michal Fishel - Bartal, MD","972-52-8087034","michalbartal@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sheba medical center","RECRUITING","Ramat Gan","Israel","IL",{"type":52,"coordinates":53},"Point",[54,55],34.81065,32.08227,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":26,"email":39},"noa gonen","972543955584",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100607046","phase-4-azithromycin-and-ampicillin-for-late-pprom-100607046",false,"NCT07183462","Azithromycin and Ampicillin for Late PPROM","ALPRO","Inclusion Criteria:\n\n* Maternal age 18-50\n* Premature rupture of membranes\n* Gestational age 34.0 and 36.4 weeks\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* Multiple gestations\n* Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)\n* Meconium stain amniotic fluid\n* Non-reassuring fetal heart rate or status\n* Maternal or fetal indication for labor:\n\n  * Suspected Chorioamnionitis\n  * Suspected placental abruption\n  * Any maternal morbidity requiring labor\n* Cervical cerclage in place.\n* Major fetal malformation or known chromosomal abnormalities.\n* Stillbirth.\n* Sensitivity to Macrolides Antibiotics","FEMALE","18 Years","50 Years",{"count":74,"type":75},311,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy.\n\nThe main question it aims to answer is:\n\nDoes the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone?\n\nResearchers will compare two antibiotic regimens:\n\nAmpicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy\n\nParticipants will:\n\nReceive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor\n\nAll participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.",[81,82,83,84,85,86],"Pregnancy Complications, Infectious","Premature Birth","Neonatal Diseases and Abnormalities","Antibiotic Prophylaxis","Latency Period","Prematurity","2025-12-10",{"date":89,"type":90},"2025-12-18","ACTUAL",{"date":92,"type":90},"2025-09-10",{"date":94,"type":75},"2029-07-31",{"name":5,"class":6},1]