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

NCT07677670 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Antenatal Care
  • Maternal Health
  • Gestational Age
  • Placenta Praevia
  • Diagnostic Imaging

Interventions

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.

Sponsors & Collaborators

  • SOIK Corporation Sarl

    lead INDUSTRY

Principal Investigators

  • Kuniyuki Furuta · SOIK Corporation

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-19
Primary Completion
2026-12-31
Completion
2027-06-13

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677670 on ClinicalTrials.gov