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

Recruiting now

Conditions studied: Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia, Diagnostic Imaging

In brief

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.

Key facts

Study ID

NCT07677670

Run by

SOIK Corporation Sarl

People needed

3000

Starts

2026-06-19

Expected to finish

2027-06-13

Last updated by the study team

2026-07-01

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women
• Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment
• Informed consent obtained (16-17 years with parent/guardian consent)

You may not qualify if…

• Emergency presentation
• Multiple pregnancy
• Duplicate re-registration of an already-enrolled woman
• Lacking capacity to consent
• Planned relocation outside Kwango province during the study period
• Refusal of consent

Where it is running

• DPS Kwango — Kenge, Kwango, Democratic Republic of the Congo (enrolling)

Full record on ClinicalTrials.gov

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