[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659292":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":45,"collaborators":13,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":13,"enrollmentInfo":57,"targetDuration":13,"studyType":60,"phases":13,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":27,"whyStopped":13,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic performance of biometric ratios and serum markers","Determination of optimal thresholds for BPD\u002FTAD and BPD\u002FPA ratios and maternal serum markers (beta-hCG and PAPP-A) for screening of open neural tube defects, by comparing their diagnostic performance alone and in combination using ROC analysis.","At first-trimester screening (retrospective data from 2011 to 2023)",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_ONLY","RETROSPECTIVE","Pregnant women undergoing routine first-trimester ultrasound screening at Strasbourg University Hospitals, including both normal pregnancies and those complicated by open neural tube defects.",[19],{"name":20,"role":21,"phone":22,"phoneExt":13,"email":23},"Chris Minella, MD","CONTACT","33 3 88 12 74 95","chris.minella@chru-strasbourg.fr",[25],{"facility":26,"status":27,"city":28,"state":13,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Service de Gynécologie et Obstétrique - CHU de Strasbourg - France","RECRUITING","Strasbourg","67091","France","FR",{"type":33,"coordinates":34},"Point",[35,36],7.74553,48.58392,{"lat":36,"lon":35},[39,40,42],{"name":20,"role":21,"phone":22,"phoneExt":13,"email":23},{"name":20,"role":41,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"name":43,"role":44,"phone":13,"phoneExt":13,"email":13},"Quitterie VIELLARD, MD","SUB_INVESTIGATOR",{"type":46,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659292","first-trimester-screening-of-open-neural-tube-defects-using-biometrics-and-maternal-serum-markers-100659292",false,"NCT07864142","First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers","Analysis of Fetal Biometrics and Maternal Serum Markers in First-Trimester Screening of Open Neural Tube Defects","BIMAS","Inclusion Criteria:\n\n* Adult pregnant woman (≥18 years)\n* First-trimester ultrasound performed at Strasbourg University Hospitals between 01\u002F01\u002F2011 and 31\u002F12\u002F2023\n* No written opposition to reuse of medical data for research purposes\n\nExclusion Criteria:\n\n* Written opposition to reuse of medical data for research purposes\n* Multiple pregnancy\n* Presence of fetal growth abnormality, morphological or genetic anomaly during pregnancy\n* Crown-rump length \\\u003C45 mm or \\>84 mm at screening ultrasound\n* Missing data\n* Fetus with closed dysraphism","FEMALE","18 Years",{"count":58,"type":59},100,"ESTIMATED","OBSERVATIONAL","Open neural tube defects are congenital malformations associated with significant morbidity. Early detection during the first trimester remains a key challenge.\n\nThis retrospective monocentric study aims to evaluate the diagnostic performance of fetal biometrics (biparietal diameter and abdominal transverse diameter ratios) and maternal serum markers (beta-hCG and PAPP-A) for early screening of open neural tube defects. The study will assess the predictive value of these parameters individually and in combination to define optimal screening thresholds applicable in routine clinical practice",[63],"Neural Tube Defects (NTDs)",[65,66,67,68,69],"Neural tube defects","Prenatal screening","First trimester","Fetal biometrics","Maternal serum markers","2026-10-01",{"date":72,"type":73},"2026-10-07","ACTUAL",{"date":75,"type":73},"2026-09-14",{"date":77,"type":59},"2026-12-14",{"name":5,"class":6},1]