Идёт набор NCT07677670

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

— Наблюдательное Antenatal Care Maternal Health Gestational Age Placenta Praevia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: SPAQ E-con AI blind-sweep ultrasound.
Кому может быть актуально: Состояния в реестре: Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia. Базовые параметры: от 16 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Democratic Republic of the Congo
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Диагностический тест 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.

Первичные конечные точки

Gestational age mean absolute error (MAE), Trimester 2 (14-27 weeks) [Срок оценки: Through study completion, up to 12 months]
Gestational age mean absolute error (MAE), Trimester 3 (28-36 weeks) [Срок оценки: Through study completion, up to 12 months]
AI confidence calibration - Expected Calibration Error (ECE) [Срок оценки: At Batch 1 closure, up to 8 weeks]
AI confidence calibration - Brier score [Срок оценки: At Batch 1 closure, up to 8 weeks]

Вторичные конечные точки (10)

Trimester 1 gestational age MAE (CRL and GS models) [Срок оценки: Through study completion, up to 12 months]
Placenta praevia and fetal malpresentation sensitivity and specificity [Срок оценки: Through study completion, up to 12 months]
Inter-rater reliability of gestational age - Intraclass Correlation Coefficient (ICC) [Срок оценки: During the inter-rater assessment window, up to 1 week]
Inter-rater reliability of placenta praevia classification - Cohen's kappa [Срок оценки: During the inter-rater assessment window, up to 1 week]
Inter-rater reliability of fetal presentation classification - weighted kappa [Срок оценки: During the inter-rater assessment window, up to 1 week]
Acceptability - Acceptability of Intervention Measure (AIM) score [Срок оценки: Through study completion, up to 12 months]
Feasibility - ultrasound throughput (scans per device per day) [Срок оценки: Through study completion, up to 12 months]
Fidelity - protocol adherence rate (5-item checklist) [Срок оценки: Through study completion, up to 12 months]
Penetration - proportion of eligible women screened [Срок оценки: Through study completion, up to 12 months]
Sustainability - intention to continue use [Срок оценки: At study completion, up to 12 months]

Критерии участия

Критерии включения

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)