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

Study acronym: krittenhouse
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: not specified → not applicable Study sites: 5 to 6 · Eligibility criteria expanded, about 9 words · Collaborators: 1 to 2 Show 3 more changesShow less
    • Study sites: 5 to 6
    • Eligibility criteria expanded, about 9 words
    • Collaborators: 1 to 2
  2. Recruitment opened Start date changed from estimate of Jun 2026 to Jun 29, 2026 · Site details revised at 5 of 5 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2026 to Jun 29, 2026
    • Site details revised at 5 of 5 sites
  3. Study sites: 4 to 5v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07661433
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Bill and Melinda Gates Foundation, NCInnovation
Conditions Fetal Weight, Pregnancy, Machine Learning, Pregnancy - Prenatal Testing
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov