[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408186":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":19,"interventions":25,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":58,"id":61,"slug":19,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":19,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":19,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":19,"briefSummary":72,"conditions":73,"keywords":19,"overallStatus":42,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Sequenom, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"NIPT clinical outcome performance","Sensitivity","9 months",{"measure":10,"description":14,"timeFrame":12},"Specificity",{"measure":10,"description":16,"timeFrame":12},"Positive predictive value",{"measure":10,"description":18,"timeFrame":12},"Negative predictive value",null,{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":21,"timePerspective":22,"maskingInfo":19},"COHORT","PROSPECTIVE","To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.","The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.",[26],{"type":27,"name":28,"description":29,"armGroupLabels":19,"otherNames":19},"DEVICE","NIPT","Non-invasive pregnancy testing",[31],{"name":32,"affiliation":33,"role":34},"Kimberly Fanelli, MS, CGC","Integrated Genetics","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":19,"email":39},"CONTACT","603-714-5063","kimberly.fanelli@integratedgenetics.com",[41],{"facility":33,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Westborough","Massachusetts","01581","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.61618,42.26954,{"lat":52,"lon":51},[55],{"name":32,"role":37,"phone":19,"phoneExt":19,"email":19},{"type":57,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[59],{"name":33,"class":60},"UNKNOWN","100408186",false,"NCT04595201","Clinical Follow-up of Pregnant Subjects Undergoing NIPT","Inclusion Criteria:\n\n* Subject was pregnant and received NIPT from Sequenom\u002FIntegrated Genetics\n* Subject was 18 years of age or older at the time of NIPT\n* Pregnancy outcome is available\n\nExclusion Criteria:\n\n* None","FEMALE","18 Years",{"count":69,"type":70},25000,"ESTIMATED","OBSERVATIONAL","To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).",[74],"Pregnancy","2024-10-11",{"date":77,"type":78},"2024-10-16","ACTUAL",{"date":80,"type":78},"2020-10-13",{"date":82,"type":70},"2025-10-13",{"name":5,"class":6},1]