Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation
Recruiting now
Conditions studied: Fetal Weight, Pregnancy, Machine Learning, Pregnancy - Prenatal Testing
In brief
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 facts
- Study ID
- NCT07661433
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 1000
- Starts
- 2026-06-29
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
- Ochsner Health — New Orleans, Louisiana, United States
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada
- University of Rwanda — Kigali, Rwanda
- University Teaching Hospital — Lusaka, Zambia
Full record on ClinicalTrials.gov
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