[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SOIK Corporation Sarl\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100645180",false,"NCT07677670","AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo","Diagnostic Accuracy and Implementation Feasibility of AI-Assisted Blind Ultrasound Sweep (SPAQ E-con AI) for Antenatal Screening by Non-Specialist Health Workers in Rural Democratic Republic of the Congo","FS2","Inclusion Criteria:\n\n* Pregnant women\n* Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment\n* Informed consent obtained (16-17 years with parent\u002Fguardian consent)\n\nExclusion Criteria:\n\n* Emergency presentation\n* Multiple pregnancy\n* Duplicate re-registration of an already-enrolled woman\n* Lacking capacity to consent\n* Planned relocation outside Kwango province during the study period\n* Refusal of consent",true,"FEMALE","16 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural Democratic Republic of the Congo. Primary outcomes are gestational age mean absolute error (Trimester 2 and Trimester 3) with 95% confidence intervals and AI confidence calibration. The reference standard is manual measurement by a reference reader (early ultrasound first; manual BPD if unavailable; last menstrual period is not used). Target enrollment is approximately 1,430 (IRB-approved ceiling 3,000), with early termination permitted upon achievement of pre-specified analysis-plan thresholds. The study is a multi-center prospective Hybrid Type 1 Effectiveness-Implementation design and includes a pre-specified adaptive model-update (Batch 2 cut) plan following FDA PCCP and STARD-AI guidance.",[25,26,27,28,29],"Antenatal Care","Maternal Health","Gestational Age","Placenta Praevia","Diagnostic Imaging",[31,32,33,34,35],"blind sweep ultrasound","artificial intelligence","point-of-care ultrasound","task-shifting","DRC","RECRUITING","2026-06-24",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":40},"2026-06-19",{"date":44,"type":21},"2027-06-13",{"name":46,"class":47},"SOIK Corporation Sarl","INDUSTRY",""]