[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"placenta-praevia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:placenta-praevia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100645180","ai-blind-sweep-ultrasound-for-antenatal-screening-by-non-specialist-health-workers-in-rural-dr-congo-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":21,"type":22},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.",[26,27,28,29,30],"Antenatal Care","Maternal Health","Gestational Age","Placenta Praevia","Diagnostic Imaging",[32,33,34,35,36],"blind sweep ultrasound","artificial intelligence","point-of-care ultrasound","task-shifting","DRC","RECRUITING","2026-06-24",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":43,"type":41},"2026-06-19",{"date":45,"type":22},"2027-06-13",{"name":47,"class":48},"SOIK Corporation Sarl","INDUSTRY"]