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

Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation

Who can join

Ages 18 and older · Women

Inclusion Criteria:

* 18 years of age or older
* Viable intrauterine pregnancy
* Delivery expected within one week of study procedures between 24 0/7 and 42 6/7 weeks, including participants with a scheduled induction or cesarean delivery on a known date, or those admitted in spontaneous labor
* Ability and willingness to provide written informed consent
* Willingness to comply with all study procedures

Exclusion Criteria:

* Maternal body mass index ≥ 40 kg/m\^2
* Multiple gestation (i.e., twins or higher order)
* Known major fetal malformation or anomaly
* Any maternal condition (medical, psychological, or social) that, in the opinion of the study team, may interfere with study participation or data integrity.

About the study

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.

What is being tested

• AI ultrasound diagnostic tool for fetal weight estimation (diagnostic test)

Sponsor: University of North Carolina, Chapel Hill · Participants: 1,000 · Started: Jun 29, 2026

Contact the study team

• Jeffrey R Stringer, MD · Phone: 919-962-4717

Official record on ClinicalTrials.gov — NCT07661433

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.