[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493305":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":18,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sulfasalazine","EXPERIMENTAL","Pregnant persons will receive sulfasalazine daily with 500 mg\u002Fdaily and increasing by 500 mg\u002Fday every week until they reach a therapeutic dose of 1,000 mg twice daily. Drug will be started at 24 weeks estimated gestational age and ended at 36 weeks or earlier if preterm birth occurs.",[13],"Drug: Sulfasalazine",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Pregnant persons will receive standard care in pregnancy.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","Sulfasalazine will be administered between 24 and 36 weeks of pregnancy",[9],[25],{"name":26,"affiliation":27,"role":28},"Emily Rosenfeld, DO","Rutgers Robert Wood Johnson Medical School","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Vanessa Martinez, MPH","CONTACT","2017379179","vm310@rwjms.rutgers.edu",{"name":26,"role":32,"phone":36,"phoneExt":18,"email":37},"7324024960","er720@rwjms.rutgers.edu",[39],{"facility":27,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","New Brunswick","New Jersey","08901","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.45182,40.48622,{"lat":50,"lon":49},[53,57],{"name":54,"role":32,"phone":55,"phoneExt":18,"email":56},"Jessica Fields, MD","732-235-6632","jf993@rwjms.rutgers.edu",{"name":58,"role":32,"phone":55,"phoneExt":18,"email":59},"Shama Khan, MS","khansp@rwjms.rutgers.edu",{"type":28,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Emily B. Rosenfeld, DO","RBHS Instructor, Divisions of Maternal-Fetal Medicine, and Epidemiology and Biostatistics","100493305","phase-2-the-effect-of-sulfasalazine-on-crh-levels-in-pregnant-women-100493305",false,"NCT05703425","The Effect of Sulfasalazine on CRH Levels in Pregnant Women","The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial","Inclusion Criteria:\n\n* \\> 18 years of age\n* Singleton pregnancy\n* Participants with a history of prior preterm birth in a previous pregnancy\n* Participants must be between 12 and 22 weeks gestation.\n* Participants must have their pregnancy dates confirmed by ultrasound.\n\nExclusion Criteria:\n\n* Participants \\\u003C 18 years old\n* Participants with a cervical length \\\u003C 25 mm\n* Participants with a multiple gestation\n* Cerclage\n* Progesterone administration\n* Unwilling or unable to swallow the study agent capsule or consume an inert ingredient in the study agent capsule\n* Acute liver disease or known liver abnormalities\n* Other significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study\n* Known hypersensitivity to sulfasalazine\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* History of severe asthma\n* Digoxin use\n* Porphyria\n* Intestinal obstruction\n* Urinary tract obstruction\n* Hepatic dysfunction\n* Renal dysfunction\n* Blood dyscrasia such as agranulocytosis, aplastic anemia.",true,"FEMALE","18 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The goal of this randomized clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth. The main questions it aims to answer are:\n\n* Does sulfasalazine down regulate corticotropin releasing hormone (CRH) levels in pregnant persons with a prior history of preterm birth?\n* Does sulfasalazine reduce the incidence of recurrent preterm birth in pregnant persons given drug vs. controls?\n\nConsenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.",[81],"Preterm Birth",[83,84,85,86],"preterm birth","sulfasalazine","corticotropin releasing hormone","randomized controlled trial","2026-07-07",{"date":89,"type":90},"2026-07-09","ACTUAL",{"date":92,"type":90},"2023-03-01",{"date":94,"type":75},"2028-06-30",{"name":5,"class":6},1]