Condition: Antenatal Care · Maternal Health · Gestational Age · Sponsor: SOIK Corporation Sarl
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.
This description comes directly from the study's public registry record.
Kuniyuki Furuta · +818099740409 · furuta@soik.co.jp
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| DPS Kwango | Kenge, Kwango, Democratic Republic of the Congo | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07677670