About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Multiple pregnancy.
Fetus in transverse lie.
Inability to provide written informed consent.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Copenhagen Academy for Medical Education and Simulation
Lead sponsor
Rigshospitalet, Denmark
Collaborator