[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04595201":3,"trial-entities:NCT04595201":79,"trial-summary:NCT04595201":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":53,"locations":56,"central_contacts":70,"overall_officials":74,"references":77,"see_also_links":78},"NCT04595201","SCMM-RND-111","Clinical Follow-up of Pregnant Subjects Undergoing NIPT","RECRUITING","2025-10-13","2024-10","2024-10-16","2020-10-13","Sequenom, Inc.","INDUSTRY",false,"To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).","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.",[18],"Pregnancy",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},25000,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"DEVICE","NIPT","Non-invasive pregnancy testing",[32,36,38,40],{"measure":33,"description":34,"timeFrame":35},"NIPT clinical outcome performance","Sensitivity","9 months",{"measure":33,"description":37,"timeFrame":35},"Specificity",{"measure":33,"description":39,"timeFrame":35},"Positive predictive value",{"measure":33,"description":41,"timeFrame":35},"Negative predictive value",[],"FEMALE","18 Years",{"inclusion":46,"exclusion":50,"raw_text":52},[47,48,49],"Subject was pregnant and received NIPT from Sequenom\u002FIntegrated Genetics","Subject was 18 years of age or older at the time of NIPT","Pregnancy outcome is available",[51],"None","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",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":67},"Integrated Genetics","Westborough","Massachusetts","01581","United States",[64],{"name":65,"role":66},"Kimberly Fanelli, MS, CGC","CONTACT",{"lat":68,"lon":69},42.26954,-71.61618,[71],{"name":65,"role":66,"phone":72,"email":73},"603-714-5063","kimberly.fanelli@integratedgenetics.com",[75],{"name":65,"affiliation":58,"role":76},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":80,"biomarkers":81},[18],[],{"nct_id":4,"found":83,"summary":84,"prompt_version":21},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an observational study planning to enroll 25,000 pregnant individuals. It is not a randomized study, meaning participants are not assigned to different treatment groups.","completed","Observational Study of NIPT in Pregnant Individuals","This study is looking at Non-invasive pregnancy testing (NIPT) in pregnant individuals. NIPT is a test that can screen for certain genetic conditions in a developing baby. The researchers want to understand how well NIPT works in real-world situations and identify factors that might be linked to difficult pregnancy outcomes. You can join if you are pregnant, are 18 or older, and have already had NIPT from Sequenom\u002FIntegrated Genetics. The study will consider NIPT's performance as successful if it accurately reflects pregnancy outcomes, measured at 9 months. The current status of this study is unclear, but it plans to include 25,000 participants.","Participants will be followed up for 9 months to measure NIPT clinical outcome performance.",102,"Not specified in the trial record.","Not stated in the trial record.",[29]]