[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645180":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":60,"armGroups":61,"interventions":75,"overallOfficials":81,"centralContacts":86,"locations":91,"responsibleParty":110,"collaborators":56,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":56,"enrollmentInfo":123,"targetDuration":56,"studyType":126,"phases":56,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":94,"whyStopped":56,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"SOIK Corporation Sarl","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":56},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Gestational age mean absolute error (MAE), Trimester 2 (14-27 weeks)","MAE in days vs reference standard, with 95% CI; target MAE ≤7 days and upper 95% CI ≤10 days","Through study completion, up to 12 months",{"measure":14,"description":15,"timeFrame":12},"Gestational age mean absolute error (MAE), Trimester 3 (28-36 weeks)","MAE in days vs reference standard, with 95% CI; target MAE ≤10 days and upper 95% CI ≤14 days",{"measure":17,"description":18,"timeFrame":19},"AI confidence calibration - Expected Calibration Error (ECE)","Expected Calibration Error from the reliability diagram of AI confidence versus reference-standard agreement; target \\\u003C=0.05","At Batch 1 closure, up to 8 weeks",{"measure":21,"description":22,"timeFrame":19},"AI confidence calibration - Brier score","Brier score of AI confidence versus reference-standard agreement; target \\\u003C=0.20",[24,27,30,34,37,40,43,46,49,52],{"measure":25,"description":26,"timeFrame":12},"Trimester 1 gestational age MAE (CRL and GS models)","Integrated Cohort A T1 + Cohort B-2, N=30; CRL model MAE ≤5 days or GS model MAE ≤7 days",{"measure":28,"description":29,"timeFrame":12},"Placenta praevia and fetal malpresentation sensitivity and specificity","Observed sensitivity\u002Fspecificity with 95% CI (Clopper-Pearson) on enriched validation subset (Cohort B-1, target N=20-25); reported as observed values",{"measure":31,"description":32,"timeFrame":33},"Inter-rater reliability of gestational age - Intraclass Correlation Coefficient (ICC)","ICC(2,1) between two independent readers for gestational age in days","During the inter-rater assessment window, up to 1 week",{"measure":35,"description":36,"timeFrame":33},"Inter-rater reliability of placenta praevia classification - Cohen's kappa","Cohen's kappa for placenta praevia (yes\u002Fno) between two independent readers",{"measure":38,"description":39,"timeFrame":33},"Inter-rater reliability of fetal presentation classification - weighted kappa","Linear weighted kappa for fetal presentation category between two independent readers",{"measure":41,"description":42,"timeFrame":12},"Acceptability - Acceptability of Intervention Measure (AIM) score","Mean AIM score (4-item, 5-point Likert) among health workers",{"measure":44,"description":45,"timeFrame":12},"Feasibility - ultrasound throughput (scans per device per day)","Number of scans completed per device per day; target \\>=15",{"measure":47,"description":48,"timeFrame":12},"Fidelity - protocol adherence rate (5-item checklist)","Percentage adherence on a 5-item fidelity checklist; target \\>=80%",{"measure":50,"description":51,"timeFrame":12},"Penetration - proportion of eligible women screened","Percentage of eligible women in the catchment screened with AI ultrasound",{"measure":53,"description":54,"timeFrame":55},"Sustainability - intention to continue use","Percentage of staff reporting intention to continue use at the end-of-study interview","At study completion, up to 12 months",null,{"allocation":56,"interventionModel":56,"interventionModelDescription":56,"primaryPurpose":56,"observationalModel":58,"timePerspective":59,"maskingInfo":56},"COHORT","PROSPECTIVE","Pregnant women attending routine antenatal care at participating facilities or identified through community health worker (RECO) village outreach in the Kenge health zone, Kwango province, DRC.",[62,67,71],{"label":63,"type":56,"description":64,"interventionNames":65},"Cohort A","Natural enrollment \u002F Description: Consecutive ANC attendees (natural prevalence)",[66],"Diagnostic Test: SPAQ E-con AI blind-sweep ultrasound",{"label":68,"type":56,"description":69,"interventionNames":70},"Cohort B-1 Placenta\u002Fmalpresentation enriched","Enriched validation subset for placenta praevia and fetal malpresentation",[66],{"label":72,"type":56,"description":73,"interventionNames":74},"Cohort B-2 - Trimester 1 (CRL\u002FGS) enriched","Enriched trimester 1 cases for CRL\u002FGS gestational age models",[66],[76],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":56},"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.",[63,68,72],[82],{"name":83,"affiliation":84,"role":85},"Kuniyuki Furuta","SOIK Corporation","PRINCIPAL_INVESTIGATOR",[87],{"name":83,"role":88,"phone":89,"phoneExt":56,"email":90},"CONTACT","+818099740409","furuta@soik.co.jp",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":56,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"DPS Kwango","RECRUITING","Kenge","Kwango","Democratic Republic of the Congo","CD",{"type":100,"coordinates":101},"Point",[102,103],17.04237,-4.80799,{"lat":103,"lon":102},[106],{"name":107,"role":88,"phone":108,"phoneExt":56,"email":109},"Henoch Bulu","+243812268392","drhenochbulu@gmail.com",{"type":111,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"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":124,"type":125},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.",[129,130,131,132,133],"Antenatal Care","Maternal Health","Gestational Age","Placenta Praevia","Diagnostic Imaging",[135,136,137,138,139],"blind sweep ultrasound","artificial intelligence","point-of-care ultrasound","task-shifting","DRC","2026-06-24",{"date":142,"type":143},"2026-07-01","ACTUAL",{"date":145,"type":143},"2026-06-19",{"date":147,"type":125},"2027-06-13",{"name":5,"class":6},1]