Clinical Trial

AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo

Study acronym: FS2
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07677670
Lead Sponsor SOIK Corporation Sarl
Conditions Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia, Diagnostic Imaging
Enrollment 3,000 participants
Start Date 2026-06-19
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-01