Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Maternal body mass index ≥ 40 kg/m²

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.

Trial design

Treatments tested in this trial

  • AI ultrasound diagnostic tool for fetal weight estimation

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

5
Canada
University of Saskatchewan SaskatoonSaskatchewan, Canada
Rwanda
University of Rwanda Kigali Rwanda
United States
Ochsner Health70115, New OrleansLouisiana, United States
University of North Carolina27516, Chapel HillNorth Carolina, United States

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

Source ClinicalTrials.gov