[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641551":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":109,"collaborators":111,"id":114,"slug":10,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":10,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":10,"enrollmentInfo":122,"targetDuration":10,"studyType":125,"phases":10,"briefSummary":126,"conditions":127,"keywords":10,"overallStatus":132,"whyStopped":10,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant Women within One Week of Delivery",null,"Participants receive a standardized ultrasound sweep protocol and specialist-performed fetal biometry.",[13],"Diagnostic Test: AI ultrasound diagnostic tool for fetal weight estimation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","AI ultrasound diagnostic tool for fetal weight estimation","Participants will undergo study-specific transabdominal ultrasound acquisition using standardized abdominal sweeps of the gravid abdomen, guided by external maternal landmarks and saved as cineloop videos. The cineloop videos will be analyzed by a locked deep-learning AI diagnostic tool to generate an estimated fetal weight. The AI-generated estimate will be compared with specialist-performed fetal biometry and actual birth weight to evaluate diagnostic accuracy. The AI output is for research evaluation only and will not direct clinical management during the study.",[9],[21],{"name":22,"affiliation":5,"role":23},"Jeffrey Stringer, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Jeffrey R Stringer, MD","CONTACT","919-962-4717","jeff_stringer@unc.edu",[31,48,66,81,95],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Ochsner Health","New Orleans","Louisiana","70115","United States",{"type":38,"coordinates":39},"Point",[40,41],-90.07507,29.95465,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":10,"email":47},"Will Williams, MD","504-842-5574","frank.williams2@ochsner.org",{"facility":49,"status":10,"city":50,"state":51,"zip":52,"country":36,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"University of North Carolina","Chapel Hill","North Carolina","27516",{"type":38,"coordinates":54},[55,56],-79.05584,35.9132,{"lat":56,"lon":55},[59,63],{"name":60,"role":27,"phone":61,"phoneExt":10,"email":62},"Katelyn J Rittenhouse, MD","919-966-5281","katelyn_rittenhouse@med.unc.edu",{"name":64,"role":27,"phone":61,"phoneExt":10,"email":65},"Jeffrey S.A. Stringer, MD","jeffrey_stringer@med.unc.edu",{"facility":67,"status":10,"city":68,"state":69,"zip":10,"country":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University of Saskatchewan","Saskatoon","Saskatchewan","Canada",{"type":38,"coordinates":72},[73,74],-106.66892,52.13238,{"lat":74,"lon":73},[77],{"name":78,"role":27,"phone":79,"phoneExt":10,"email":80},"Scott Adams, MD, PhD","(306) 655-2402","scott.adams@usask.ca",{"facility":82,"status":10,"city":83,"state":10,"zip":10,"country":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University of Rwanda","Kigali","Rwanda",{"type":38,"coordinates":86},[87,88],30.05885,-1.94995,{"lat":88,"lon":87},[91],{"name":92,"role":27,"phone":93,"phoneExt":10,"email":94},"Stephen Rulisa, MD, PhD","+250788571436","s.rulisa@gmail.com",{"facility":96,"status":10,"city":97,"state":10,"zip":10,"country":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"University Teaching Hospital","Lusaka","Zambia",{"type":38,"coordinates":100},[101,102],28.28713,-15.40669,{"lat":102,"lon":101},[105],{"name":106,"role":27,"phone":107,"phoneExt":10,"email":108},"Margaret Kasaro, MBChB, MMed, MSc","+260963223210","margaret.kasaro@unclusaka.org",{"type":110,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[112],{"name":113,"class":6},"Bill and Melinda Gates Foundation","100641551",false,"NCT07661433","Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Inclusion Criteria:\n\n* 18 years of age or older\n* Viable intrauterine pregnancy\n* Delivery expected within one week of study procedures between 24 0\u002F7 and 42 6\u002F7 weeks, including participants with a scheduled induction or cesarean delivery on a known date, or those admitted in spontaneous labor\n* Ability and willingness to provide written informed consent\n* Willingness to comply with all study procedures\n\nExclusion Criteria:\n\n* Maternal body mass index ≥ 40 kg\u002Fm\\^2\n* Multiple gestation (i.e., twins or higher order)\n* Known major fetal malformation or anomaly\n* Any maternal condition (medical, psychological, or social) that, in the opinion of the study team, may interfere with study participation or data integrity.","FEMALE","18 Years",{"count":123,"type":124},1000,"ESTIMATED","OBSERVATIONAL","Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.",[128,129,130,131],"Fetal Weight","Pregnancy","Machine Learning","Pregnancy - Prenatal Testing","NOT_YET_RECRUITING","2026-06-22",{"date":135,"type":136},"2026-06-25","ACTUAL",{"date":138,"type":124},"2026-06",{"date":140,"type":124},"2026-12",{"name":5,"class":6},5]