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

Recruitingn/aAges 18 Years - anyFemaleSOIK Corporation Sarl
NCT07677670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). Planned enrollment is approximately 1,380: Batch 1 (closed, 80 enrolled) and Batch 2 (approximately 1,300), within an IRB-approved ceiling of 3,000. Early termination is permitted upon achievement of pre-specified analysis-plan thresholds. The study is a multi-center prospective Hybrid Type 1 Effectiveness-Implementation design and includes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women aged 18 years or older * Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment * Written informed consent obtained Exclusion Criteria: * Emergency presentation * Duplicate re-registration of an already-enrolled woman * Lacking capacity to consent * Planned relocation outside Kwango province during the study period * Refusal of consent
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What it tests

  • SPAQ E-con AI blind-sweep ultrasound
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Where

1 site
Centre de Sante CBCO
Kenge, Democratic Republic of the Congo
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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