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NCT Number: NCT07677670

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

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.

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Key information

Conditions

Antenatal Care Diagnostic Imaging Female Urogenital Diseases and Pregnancy Complications Gestational Age Maternal Health Obstetric Labor Complications Placenta Diseases Placenta Praevia Placenta Previa Pregnancy Complications Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

DPS Kwango

Kenge, Kwango, Democratic Republic of the Congo

Location status: Recruiting

Location contact

Henoch Bulu

CONTACT

[email protected]

+243812268392

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

SPAQ E-con AI blind-sweep ultrasound

Diagnostic Test

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.

Primary outcomes

  1. Gestational age mean absolute error (MAE), Trimester 2 (14-27 weeks)

    Time frame: Through study completion, up to 12 months

    MAE in days vs reference standard, with 95% CI; target MAE ≤7 days and upper 95% CI ≤10 days

  2. Gestational age mean absolute error (MAE), Trimester 3 (28-36 weeks)

    Time frame: Through study completion, up to 12 months

    MAE in days vs reference standard, with 95% CI; target MAE ≤10 days and upper 95% CI ≤14 days

  3. AI confidence calibration - Expected Calibration Error (ECE)

    Time frame: At Batch 1 closure, up to 8 weeks

    Expected Calibration Error from the reliability diagram of AI confidence versus reference-standard agreement; target <=0.05

  4. AI confidence calibration - Brier score

    Time frame: At Batch 1 closure, up to 8 weeks

    Brier score of AI confidence versus reference-standard agreement; target <=0.20

Secondary outcomes

  1. Trimester 1 gestational age MAE (CRL and GS models)

    Time frame: Through study completion, up to 12 months

    Integrated Cohort A T1 + Cohort B-2, N=30; CRL model MAE ≤5 days or GS model MAE ≤7 days

  2. Placenta praevia and fetal malpresentation sensitivity and specificity

    Time frame: Through study completion, up to 12 months

    Observed sensitivity/specificity with 95% CI (Clopper-Pearson) on enriched validation subset (Cohort B-1, target N=20-25); reported as observed values

  3. Inter-rater reliability of gestational age - Intraclass Correlation Coefficient (ICC)

    Time frame: During the inter-rater assessment window, up to 1 week

    ICC(2,1) between two independent readers for gestational age in days

  4. Inter-rater reliability of placenta praevia classification - Cohen's kappa

    Time frame: During the inter-rater assessment window, up to 1 week

    Cohen's kappa for placenta praevia (yes/no) between two independent readers

  5. Inter-rater reliability of fetal presentation classification - weighted kappa

    Time frame: During the inter-rater assessment window, up to 1 week

    Linear weighted kappa for fetal presentation category between two independent readers

  6. Acceptability - Acceptability of Intervention Measure (AIM) score

    Time frame: Through study completion, up to 12 months

    Mean AIM score (4-item, 5-point Likert) among health workers

  7. Feasibility - ultrasound throughput (scans per device per day)

    Time frame: Through study completion, up to 12 months

    Number of scans completed per device per day; target >=15

  8. Fidelity - protocol adherence rate (5-item checklist)

    Time frame: Through study completion, up to 12 months

    Percentage adherence on a 5-item fidelity checklist; target >=80%

  9. Penetration - proportion of eligible women screened

    Time frame: Through study completion, up to 12 months

    Percentage of eligible women in the catchment screened with AI ultrasound

  10. Sustainability - intention to continue use

    Time frame: At study completion, up to 12 months

    Percentage of staff reporting intention to continue use at the end-of-study interview

Study contacts

Contact information is provided by the study sponsor or research team.

Kuniyuki Furuta

CONTACT

[email protected]

+818099740409

Sponsors and collaborators

Lead sponsor

SOIK Corporation Sarl

Industry

Registry information

Official study title

Diagnostic Accuracy and Implementation Feasibility of AI-Assisted Blind Ultrasound Sweep (SPAQ E-con AI) for Antenatal Screening by Non-Specialist Health Workers in Rural Democratic Republic of the Congo

Acronym: FS2

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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