[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100072565":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":154,"collaborators":156,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":10,"studyType":174,"phases":10,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: aPL+\u002FSLE-",null,"Positive antiphospholipid antibodies (aPL) defined as positive LAC and\u002For anti cardiolipin IgG\u002FIgM \\>= 40 units and\u002For anti-beta 2 glycoprotein I IgG or IgM \\>= 40 units; no SLE",{"label":13,"type":10,"description":14,"interventionNames":10},"Group 2: aPL+\u002FSLE+","Positive antiphospholipid antibodies (aPL) defined as positive LAC and\u002For anti cardiolipin IgG\u002FIgM \\>= 40 units and\u002For anti-beta 2 glycoprotein I IgG or IgM \\>= 40 units AND SLE defined as four or more American College of Rheumatology criteria for SLE.",{"label":16,"type":10,"description":17,"interventionNames":10},"Group 3: aPL-\u002FSLE+","No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE.",{"label":19,"type":10,"description":20,"interventionNames":10},"Group 4: aPL-\u002FSLE-","Healthy controls: no antiphospholipid antibodies; no SLE",[22],{"name":23,"affiliation":5,"role":24},"Jane E. Salmon, M.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Marta M. Guerra, MS","CONTACT","212-774-7361","guerram@hss.edu",[32,46,52,62,77,89,95,105,124,143],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"Northwestern University","COMPLETED","Chicago","Illinois","60611","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},{"facility":47,"status":34,"city":35,"state":36,"zip":48,"country":38,"countryCode":39,"cosmosGeoPoint":49,"geoPoint":51,"contacts":10},"University of Chicago","60637",{"type":41,"coordinates":50},[43,44],{"lat":44,"lon":43},{"facility":53,"status":34,"city":54,"state":55,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":10},"Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":41,"coordinates":58},[59,60],-76.61219,39.29038,{"lat":60,"lon":59},{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":38,"countryCode":39,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"NYU Langone Medical Center\u002FHospital for Joint Diseases","RECRUITING","New York","10016",{"type":41,"coordinates":68},[69,70],-74.00597,40.71427,{"lat":70,"lon":69},[73,75],{"name":74,"role":28,"phone":29,"phoneExt":10,"email":30},"Marta M Guerra, MS",{"name":76,"role":24,"phone":10,"phoneExt":10,"email":10},"Jill P. 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Sinai Hospital","Toronto","Ontario","M5G 2K4","Canada","CA",{"type":41,"coordinates":132},[133,134],-79.39864,43.70643,{"lat":134,"lon":133},[137,141],{"name":138,"role":28,"phone":139,"phoneExt":10,"email":140},"Karen Spitzer","416-506-9203","kspitzer@triofertility.com",{"name":142,"role":24,"phone":10,"phoneExt":10,"email":10},"Carl Laskin, M.D.",{"facility":144,"status":34,"city":145,"state":10,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":10},"Guy's & St Thomas' NHS Foundation Trust","London","SE1 7EH","United Kingdom","UK",{"type":41,"coordinates":150},[151,152],-0.12574,51.50853,{"lat":152,"lon":151},{"type":155,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[157],{"name":158,"class":159},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH","100072565","predictors-of-pregnancy-outcome-in-systemic-lupus-erythematosus-sle-and-antiphospholipid-syndrome-aps-100072565",false,"NCT00198068","Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)","PROMISSE","Inclusion Criteria:\n\n* Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)\n* Patient between the ages of 18-45 and able to give informed consent, or age \\\u003C 18 years with parental consent\n* Hematocrit \\> 26%\n* For APL positive:\n\n  * aCL: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n  * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)\n  * Anti-β2GPI: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n* For control subjects:\n\n  * At least one successful pregnancy\n  * No history of fetal death (death of conceptus ≥ 10 weeks' gestation)\n  * No more than 1 miscarriage \\\u003C 10 weeks' gestation\n  * No history of positive aPL in local lab or positive aPL in core labs at screening\n  * Not currently a smoker\n  * No medical problems requiring chronic treatment\n\nExclusion Criteria:\n\n* Diabetes mellitus (Type I and Type II) antedating pregnancy\n* Known or suspected hereditary complement deficiency (defined by CH50 = 0)",true,"FEMALE","18 Years","45 Years",{"count":172,"type":173},700,"ESTIMATED","OBSERVATIONAL","The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and\u002For 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and\u002For SLE.",[177,178],"Systemic Lupus Erythematosus","Antiphospholipid Syndrome",[180,181,182],"Pregnancy outcomes","Systemic lupus erythematosus","Antiphospholipid syndrome","2026-04-23",{"date":185,"type":186},"2026-04-28","ACTUAL",{"date":188,"type":10},"2003-09",{"date":190,"type":173},"2027-03",{"name":5,"class":6},10]