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.
Pregnant women aged ≥18 years.
Singleton pregnancy.
Gestational age ≥28+0 weeks.
Fetus in longitudinal lie (cephalic or breech presentation) as determined by the routine clinical ultrasound examination.
Multiple pregnancy.
Fetus in transverse lie.
Inability to provide written informed consent.
Pregnant women with singleton pregnancies attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse Hospital, or Hillerød Hospital.
Cohort
Prospective
Not listed
Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation.
Overall proportion of correct AI predictions of fetal lie and presentation compared with expert clinician assessment (reference standard).
Agreement between AI predictions and expert clinician assessment.
Agreement will be evaluated using Cohen's kappa coefficient.
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Copenhagen Academy for Medical Education and Simulation
Lead sponsor
Rigshospitalet, Denmark
Collaborator
