An interventional study of AI ultrasound diagnostic tool for fetal weight estimation in Fetal Weight, Pregnancy and Machine Learning, sponsored by University of North Carolina, Chapel Hill. Recruiting at 6 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Diagnostic
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.
17 studies on the registry are indexed under Fetal Weight; 7 are open to participants now.
Browse Fetal Weight studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a standardized ultrasound sweep protocol and specialist-performed fetal biometry within one week of delivery
Diagnostic Test: AI ultrasound diagnostic tool for fetal weight estimation
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.
Difference in Mean Absolute Percent Error (MAPE) in fetal weight estimation
Mean of pairwise differences in absolute percent error between the AI diagnostic tool (index test) and specialist biometry (clinical reference standard), compared against actual birthweight (ground truth).
Time frame: Within 1 week of delivery, 24-42 weeks of gestation
Proportion of fetal weight estimates within 10% of actual birthweight
Between-method difference in the proportion of estimates within 10% of actual birthweight (ground truth) for the AI diagnostic tool (index test) versus specialist biometry (clinical reference standard).
Time frame: Within 1 week of delivery, 24-42 weeks of gestation
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Informed consent form
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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