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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07661433
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AI ultrasound diagnostic tool for fetal weight estimation — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Jun 29, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Pregnant Women within One Week of Delivery
    Participants receive a standardized ultrasound sweep protocol and specialist-performed fetal biometry.

Primary Outcome Measure

Difference in Mean Absolute Percent Error (MAPE) in fetal weight estimation [ Time Frame: Within 1 week of delivery, 24-42 weeks of gestation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ochsner HealthNew OrleansLouisiana70115
Will Williams, MD
[email protected]
504-842-5574
University of North CarolinaChapel HillNorth Carolina27516
Katelyn J Rittenhouse, MD
[email protected]
919-966-5281
Jeffrey S.A. Stringer, MD
[email protected]
919-966-5281

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By research site
Ochsner Health· New Orleans, LAUniversity of North Carolina· Chapel Hill, NC

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