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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorCopenhagen Academy for Medical Education and Simulation

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

150 Participants
are grouped into 1 trial group

Sponsors and collaborators