Clinical Research Directory

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). Planned enrollment is approximately 1,380: Batch 1 (closed, 80 enrolled) and Batch 2 (approximately 1,300), within an IRB-approved ceiling of 3,000. Early termination is 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.

Transverse Cerebellar Diameter and Abdominal Circumference Ratio Versus Mid-Thigh Circumference and Femur Length Ratio in Assessment of Gestational Age in Normal and Growth Restricted Fetuses

The aim of this research was to examine the accuracy of transcerebellar diameter to abdominal circumference ratio (TCD/AC) and mid-thigh circumference and femur length (MTC/FL) in estimating the gestational age of healthy and abnormally growing fetuses.