[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640593":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":70,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":26,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AutoFUSE-assisted ultrasound scan","EXPERIMENTAL","AutoFUSE-assisted ultrasound scanning throughout the examination.",[13],"Diagnostic Test: AutoFUSE system",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional ultrasound scan","ACTIVE_COMPARATOR","Standard ultrasound scanning according to the standard clinical protocol.",[19],"Diagnostic Test: Traditional ultrasound scan",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","AutoFUSE system","AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Traditional ultrasound scan means the standard clinical ultrasound examination performed by sonographers using routine manual operation to acquire predefined standard anatomical planes, without real-time AI assistance, automatic plane recognition, or automatic image quality assessment. All plane acquisition and quality evaluation are completed manually by the operator.",[15],[31,50,60],{"facility":32,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Wuhan Union Hospital","Wuhan","Hubei","430022","China","CN",{"type":39,"coordinates":40},"Point",[41,42],114.26667,30.58333,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Lei Chen, MD","CONTACT","15971480677","chan0812@126.com",{"facility":51,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Zhongnan Hospital of Wuhan University",{"type":39,"coordinates":53},[41,42],{"lat":42,"lon":41},[56],{"name":57,"role":47,"phone":58,"phoneExt":26,"email":59},"Huangxuan Zhao, PhD","18971676985","zhao_huangxuan@sina.com",{"facility":61,"status":26,"city":33,"state":34,"zip":62,"country":36,"countryCode":37,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Renmin Hospital of Wuhan University","430060",{"type":39,"coordinates":64},[41,42],{"lat":42,"lon":41},[67],{"name":68,"role":47,"phone":69,"phoneExt":26,"email":49},"Yong Luo, PhD","15210624692",{"type":71,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640593","autofuse-or-first-trimester-ultrasound-scan-100640593",false,"NCT07601191","AutoFUSE or First-Trimester Ultrasound Scan","Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China","Inclusion Criteria:\n\n① Pregnant women undergoing fetal ultrasound examination.\n\n② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.\n\nExclusion Criteria:\n\n* Incomplete pregnancy outcome information.\n\n  * Unexplained miscarriages. ③ Fetal death.\n\n    * Pregnancies with significant maternal complications.\n\n      * Multiple pregnancies.",true,"FEMALE",{"count":82,"type":83},1000,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to validate the clinical application capabilities of AutoFUSE. The main questions it aims to answer are:\n\nDoes AutoFUSE reduce the time required to obtain standard planes in first-trimester ultrasound scan? Does AutoFUSE improve the accuracy of standard plane acquisition in first-trimester ultrasound scan? What safety outcomes occur in participants undergoing AutoFUSE-assisted ultrasound examination? Researchers will compare AutoFUSE-assisted ultrasound scan with standard clinical protocol (SCP) ultrasound scan to evaluate the efficacy and safety of AutoFUSE in clinical practice.\n\nParticipants will:\n\nUndergo either AutoFUSE-assisted ultrasound scan or standard clinical ultrasound scan according to the study design.\n\nComplete scheduled visits for examinations, data collection and follow-up. Provide information related to scan time, image quality and safety during the study.",[89],"Fetus Disorder",[91,92,93,94,95],"First-trimester ultrasound","Artificial intelligence","Standard plane","Image quality control","Randomized clinical trial","NOT_YET_RECRUITING","2026-05-20",{"date":99,"type":100},"2026-05-22","ACTUAL",{"date":102,"type":83},"2026-06-01",{"date":104,"type":83},"2026-12-31",{"name":5,"class":6},3]