[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645180":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"SOIK Corporation Sarl","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A",null,"Natural enrollment \u002F Description: Consecutive ANC attendees (natural prevalence)",[13],"Diagnostic Test: SPAQ E-con AI blind-sweep ultrasound",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B-1 Placenta\u002Fmalpresentation enriched","Enriched validation subset for placenta praevia and fetal malpresentation",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort B-2 - Trimester 1 (CRL\u002FGS) enriched","Enriched trimester 1 cases for CRL\u002FGS gestational age models",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","SPAQ E-con AI blind-sweep ultrasound","Smartphone-based 9-sweep obstetric ultrasound with AI estimation of gestational age, fetal presentation, and placenta location, operated by trained non-specialist health workers after 30-60 minutes of training.",[9,15,19],[29],{"name":30,"affiliation":31,"role":32},"Kuniyuki Furuta","SOIK Corporation","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","+818099740409","furuta@soik.co.jp",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"DPS Kwango","RECRUITING","Kenge","Kwango","Democratic Republic of the Congo","CD",{"type":47,"coordinates":48},"Point",[49,50],17.04237,-4.80799,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":10,"email":56},"Henoch Bulu","+243812268392","drhenochbulu@gmail.com",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":71,"type":72},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.",[76,77,78,79,80],"Antenatal Care","Maternal Health","Gestational Age","Placenta Praevia","Diagnostic Imaging",[82,83,84,85,86],"blind sweep ultrasound","artificial intelligence","point-of-care ultrasound","task-shifting","DRC","2026-06-24",{"date":89,"type":90},"2026-07-01","ACTUAL",{"date":92,"type":90},"2026-06-19",{"date":94,"type":72},"2027-06-13",{"name":5,"class":6},1]