Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester

This prospective clinical validation study aims to evaluate the diagnostic performance of an artificial intelligence (AI)-based navigational support system for determining fetal lie and presentation during third-trimester ultrasound examinations. Following routine clinical assessment by an expert clinician, three blind ultrasound sweeps will be obtained from each participant. The AI system will generate predictions of fetal lie and presentation from each sweep, which will be compared with the expert clinician's assessment as the reference standard. The study will also explore clinician perceptions of the system's usability and potential clinical value.

NCT Number	NCT07754071
Lead Sponsor	Copenhagen Academy for Medical Education and Simulation Collaborators: Rigshospitalet, Denmark
Conditions	Pregnancy, Fetal Presentation, Breech Fetal Presentation, Cephalic Fetal Presentation
Enrollment	150 participants
Start Date	2025-09-11
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-10