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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Natural enrollment / Description: Consecutive ANC attendees (natural prevalence) |
| |
| Cohort B-1 Placenta/malpresentation enriched | Enriched validation subset for placenta praevia and fetal malpresentation |
| |
| Cohort B-2 - Trimester 1 (CRL/GS) enriched | Enriched trimester 1 cases for CRL/GS gestational age models |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age mean absolute error (MAE), Trimester 2 (14-27 weeks) | MAE in days vs reference standard, with 95% CI; target MAE ≤7 days and upper 95% CI ≤10 days | Through study completion, up to 12 months |
| Gestational age mean absolute error (MAE), Trimester 3 (28-36 weeks) | MAE in days vs reference standard, with 95% CI; target MAE ≤10 days and upper 95% CI ≤14 days | Through study completion, up to 12 months |
| AI confidence calibration - Expected Calibration Error (ECE) | Expected Calibration Error from the reliability diagram of AI confidence versus reference-standard agreement; target <=0.05 | At Batch 1 closure, up to 8 weeks |
| AI confidence calibration - Brier score | Brier score of AI confidence versus reference-standard agreement; target <=0.20 | At Batch 1 closure, up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trimester 1 gestational age MAE (CRL and GS models) | Integrated Cohort A T1 + Cohort B-2, N=30; CRL model MAE ≤5 days or GS model MAE ≤7 days | Through study completion, up to 12 months |
| Placenta praevia and fetal malpresentation sensitivity and specificity |
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Inclusion Criteria:
Exclusion Criteria:
Female
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Pregnant women attending routine antenatal care at participating facilities or identified through community health worker (RECO) village outreach in the Kenge health zone, Kwango province, DRC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuniyuki Furuta | Contact | +818099740409 | furuta@soik.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Kuniyuki Furuta | SOIK Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DPS Kwango | Recruiting | Kenge | Kwango | Democratic Republic of the Congo |
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Observed sensitivity/specificity with 95% CI (Clopper-Pearson) on enriched validation subset (Cohort B-1, target N=20-25); reported as observed values |
| Through study completion, up to 12 months |
| Inter-rater reliability of gestational age - Intraclass Correlation Coefficient (ICC) | ICC(2,1) between two independent readers for gestational age in days | During the inter-rater assessment window, up to 1 week |
| Inter-rater reliability of placenta praevia classification - Cohen's kappa | Cohen's kappa for placenta praevia (yes/no) between two independent readers | During the inter-rater assessment window, up to 1 week |
| Inter-rater reliability of fetal presentation classification - weighted kappa | Linear weighted kappa for fetal presentation category between two independent readers | During the inter-rater assessment window, up to 1 week |
| Acceptability - Acceptability of Intervention Measure (AIM) score | Mean AIM score (4-item, 5-point Likert) among health workers | Through study completion, up to 12 months |
| Feasibility - ultrasound throughput (scans per device per day) | Number of scans completed per device per day; target >=15 | Through study completion, up to 12 months |
| Fidelity - protocol adherence rate (5-item checklist) | Percentage adherence on a 5-item fidelity checklist; target >=80% | Through study completion, up to 12 months |
| Penetration - proportion of eligible women screened | Percentage of eligible women in the catchment screened with AI ultrasound | Through study completion, up to 12 months |
| Sustainability - intention to continue use | Percentage of staff reporting intention to continue use at the end-of-study interview | At study completion, up to 12 months |
| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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