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Recruiting NCT07677670

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

— Observational Antenatal Care Maternal Health Gestational Age Placenta Praevia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPAQ E-con AI blind-sweep ultrasound.
Who it may be relevant to
Registry conditions: Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia. Basic parameters: from 16 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Democratic Republic of the Congo
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Primary outcome measures

  • Gestational age mean absolute error (MAE), Trimester 2 (14-27 weeks) [Time frame: Through study completion, up to 12 months]
  • Gestational age mean absolute error (MAE), Trimester 3 (28-36 weeks) [Time frame: Through study completion, up to 12 months]
  • AI confidence calibration - Expected Calibration Error (ECE) [Time frame: At Batch 1 closure, up to 8 weeks]
  • AI confidence calibration - Brier score [Time frame: At Batch 1 closure, up to 8 weeks]
Secondary outcome measures (10)
  • Trimester 1 gestational age MAE (CRL and GS models) [Time frame: Through study completion, up to 12 months]
  • Placenta praevia and fetal malpresentation sensitivity and specificity [Time frame: Through study completion, up to 12 months]
  • Inter-rater reliability of gestational age - Intraclass Correlation Coefficient (ICC) [Time frame: During the inter-rater assessment window, up to 1 week]
  • Inter-rater reliability of placenta praevia classification - Cohen's kappa [Time frame: During the inter-rater assessment window, up to 1 week]
  • Inter-rater reliability of fetal presentation classification - weighted kappa [Time frame: During the inter-rater assessment window, up to 1 week]
  • Acceptability - Acceptability of Intervention Measure (AIM) score [Time frame: Through study completion, up to 12 months]
  • Feasibility - ultrasound throughput (scans per device per day) [Time frame: Through study completion, up to 12 months]
  • Fidelity - protocol adherence rate (5-item checklist) [Time frame: Through study completion, up to 12 months]
  • Penetration - proportion of eligible women screened [Time frame: Through study completion, up to 12 months]
  • Sustainability - intention to continue use [Time frame: At study completion, up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Democratic Republic of the Congo · 1 center
  • DPS Kwango — Kenge

Identifiers

NCT: NCT07677670 · SOIK-FS2-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗