[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640593":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":29,"interventions":42,"overallOfficials":18,"centralContacts":18,"locations":51,"responsibleParty":91,"collaborators":18,"id":93,"slug":18,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":18,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":18,"maxAge":18,"enrollmentInfo":101,"targetDuration":18,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":116,"whyStopped":18,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"The efficiency of standard plane acquisition","The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.","Day 1",[14],{"measure":15,"description":16,"timeFrame":17},"The accuracy of standard plane acquisition","The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria.","Through study completion, an average of 6 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":24,"maskingDescription":18,"whoMasked":25},"TRIPLE",[26,27,28],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"AutoFUSE-assisted ultrasound scan","EXPERIMENTAL","AutoFUSE-assisted ultrasound scanning throughout the examination.",[35],"Diagnostic Test: AutoFUSE system",{"label":37,"type":38,"description":39,"interventionNames":40},"Traditional ultrasound scan","ACTIVE_COMPARATOR","Standard ultrasound scanning according to the standard clinical protocol.",[41],"Diagnostic Test: Traditional ultrasound scan",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"DIAGNOSTIC_TEST","AutoFUSE system","AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).",[31],{"type":44,"name":37,"description":49,"armGroupLabels":50,"otherNames":18},"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.",[37],[52,71,81],{"facility":53,"status":18,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Wuhan Union Hospital","Wuhan","Hubei","430022","China","CN",{"type":60,"coordinates":61},"Point",[62,63],114.26667,30.58333,{"lat":63,"lon":62},[66],{"name":67,"role":68,"phone":69,"phoneExt":18,"email":70},"Lei Chen, MD","CONTACT","15971480677","chan0812@126.com",{"facility":72,"status":18,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Zhongnan Hospital of Wuhan University",{"type":60,"coordinates":74},[62,63],{"lat":63,"lon":62},[77],{"name":78,"role":68,"phone":79,"phoneExt":18,"email":80},"Huangxuan Zhao, PhD","18971676985","zhao_huangxuan@sina.com",{"facility":82,"status":18,"city":54,"state":55,"zip":83,"country":57,"countryCode":58,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Renmin Hospital of Wuhan University","430060",{"type":60,"coordinates":85},[62,63],{"lat":63,"lon":62},[88],{"name":89,"role":68,"phone":90,"phoneExt":18,"email":70},"Yong Luo, PhD","15210624692",{"type":92,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":102,"type":103},1000,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109],"Fetus Disorder",[111,112,113,114,115],"First-trimester ultrasound","Artificial intelligence","Standard plane","Image quality control","Randomized clinical trial","NOT_YET_RECRUITING","2026-05-20",{"date":119,"type":120},"2026-05-22","ACTUAL",{"date":122,"type":103},"2026-06-01",{"date":124,"type":103},"2026-12-31",{"name":5,"class":6},3]