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

NCT07661433 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Fetal Weight
  • Pregnancy
  • Machine Learning
  • Pregnancy - Prenatal Testing

Interventions

DIAGNOSTIC_TEST

AI ultrasound diagnostic tool for fetal weight estimation

Participants will undergo study-specific transabdominal ultrasound acquisition using standardized abdominal sweeps of the gravid abdomen, guided by external maternal landmarks and saved as cineloop videos. The cineloop videos will be analyzed by a locked deep-learning AI diagnostic tool to generate an estimated fetal weight. The AI-generated estimate will be compared with specialist-performed fetal biometry and actual birth weight to evaluate diagnostic accuracy. The AI output is for research evaluation only and will not direct clinical management during the study.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jeffrey Stringer, MD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Rwanda
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661433 on ClinicalTrials.gov