[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607488":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":42,"responsibleParty":82,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":26,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Counseling and intensified testing and, if negative, Benzathine Penicillin G","EXPERIMENTAL","Counseling about prevention of STIs at each pre-natal visit. Treponemal and non-treponemal tests every four weeks beginning at the 28th week of pregnancy and at delivery. If negative, IM injection of 2.4 million units of Benzathine Penicillin G. If positive, syphilis treatment based on the guidelines of the Brazilian Ministry of Health.",[13,14],"Drug: Benzathine penicillin 2.4 million units","Behavioral: Counseling and intensified testing.",{"label":16,"type":17,"description":18,"interventionNames":19},"Counseling and intensified testing without using Benzathine Penicillin G","ACTIVE_COMPARATOR","Counseling about prevention of STIs at each pre-natal visit. Treponemal and non-treponemal tests every four weeks beginning at the 28th week of pregnancy and at delivery. If positive, syphilis treatment based on the guidelines of the Brazilian Ministry of Health.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Benzathine penicillin 2.4 million units","IM injection of BPG",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Counseling and intensified testing.","Brazilian Ministry of Health guidelines for the prevention and diagnosis of maternal syphilis consist of counseling about STI prevention and syphilis testing at the first pre-natal consultation, at a subsequent consultation during or after 28 weeks of pregnancy, at delivery, and in case of abortion or stillbirth. In this study, intensified testing refers to treponemal and non-treponemal tests once every four weeks beginning as of the 28th week of pregnancy.",[9,16],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Karin Nielsen, MD","CONTACT","310-825-5235","knielsen@mednet.ucla.edu",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Esaú C João, MD, PhD","+55 (21) 2233-0018","esaujoao@gmail.com",[43,59,68,75],{"facility":44,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)","NOT_YET_RECRUITING","Duque de Caxias","Rio de Janeiro","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-43.31167,-22.78556,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":40,"phoneExt":26,"email":41},"Esaú C. João",{"facility":60,"status":61,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Policlínica Hospital Municipal Duque de Caxias","RECRUITING",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":35,"phone":40,"phoneExt":26,"email":41},"Esaú C. João, MD, PhD",{"facility":69,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Unidade Básica de Saúde José de Freitas",{"type":51,"coordinates":71},[53,54],{"lat":54,"lon":53},[74],{"name":67,"role":35,"phone":40,"phoneExt":26,"email":41},{"facility":76,"status":61,"city":47,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":26},"Hospital Federal dos Servidores do Estado",{"type":51,"coordinates":78},[79,80],-43.18223,-22.90642,{"lat":80,"lon":79},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Karin Nielsen","Professor of Clinical",[87],{"name":88,"class":89},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100607488","phase-2-evaluation-of-antimicrobial-prophylaxis-to-prevent-syphilis-in-pregnancy-in-patients-at-risk-in-rio-de-janeiro-brazil-100607488",false,"NCT07189208","Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil","PRESERvE","Inclusion Criteria:\n\n1. Uncomplicated, viable pregnancy\n2. Elevated risk for syphilis acquisition (one or more of the following):\n\n   1. Prior history of STIs last 3 years\n   2. HIV infection\n   3. Age \\\u003C 21 years\n   4. In a sexual partnership of \\\u003C 3 mo., or \\> 3 sexual partners in the last 6 mo.\n   5. Late initiation of prenatal care (\\> 14 weeks of pregnancy)\n   6. Residence in area where syphilis prevalence is 10% or higher.\n3. Ability to provide written informed consent\n4. No allergy to penicillin\n5. Prenatal care at one of the sites participating in the study\n6. Ongoing sexual activity during study period.\n7. Negative rapid treponemal test at baseline.\n\nExclusion Criteria:\n\n1. Non-viable pregnancy\n2. Very high risk pregnancy\n3. Inability to provide written informed consent\n4. Allergy to penicillin\n5. Positive rapid treponemal test at baseline\n6. Lack of sexual activity during study period.\n7. Any persisting coagulation disorder that would contraindicate IM injections.",true,"FEMALE","18 Years","45 Years",{"count":102,"type":103},500,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The goal of this clinical trial is to learn if benzathine penicillin works to prevent maternal syphilis. It will also learn about the safety of benzathine penicillin. The main questions it aims to answer are:\n\n* Does benzathine penicillin lower the rate of syphilis in pregnancy?\n* What medical problems do participants have when taking benzathine penicillin? Researchers will compare benzathine penicillin to routine care to see if benzathine penicillin works to prevent syphilis.\n\nParticipants will:\n\n* Take benzathine penicillin or receive routine care during the third trimester of pregnancy\n* Visit the clinic once a month for injections and tests\n* Report any reactions to benzathine penicillin to the study team",[109],"Congenital Syphilis",[111],"congenital syphilis","2026-05-28",{"date":114,"type":115},"2026-06-01","ACTUAL",{"date":117,"type":115},"2025-09-24",{"date":119,"type":103},"2030-07-31",{"name":5,"class":6},4]