Clinical Trial

Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation

Recruiting
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Summary
Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-09
Trial Details
NCT Number NCT07661433
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Bill and Melinda Gates Foundation
Conditions Fetal Weight, Pregnancy, Machine Learning, Pregnancy - Prenatal Testing
Enrollment 1,000 participants
Start Date 2026-06-29
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-08