Clinical trialNCT07661433RecruitingInterventional

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

SponsorUniversity of North Carolina, Chapel HillEnrollment1,000Fetal WeightMachine LearningPregnancyPregnancy - Prenatal Testing

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Katelyn J Rittenhouse, MD
University of North Carolina, Chapel Hill
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Not, yet, recruiting

Rwanda

University of Rwanda
Kigali, Rwanda
Not, yet, recruiting

United States

Ochsner Health
New Orleans, Louisiana, United States
Not, yet, recruiting
University of North Carolina
Chapel Hill, North Carolina, United States
Recruiting
the Ohio State University
Columbus, Ohio, United States
Not, yet, recruiting

Zambia

University Teaching Hospital
Lusaka, Zambia
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Jun 2026
Primary completion: 31 Dec 2026
Completion: 31 Dec 2026
Last update posted: 6 Oct 2026
Registered enrollment: 1,000
Registry id: NCT07661433

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.