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

Recruitingn/aAges 18 Years - 70 YearsFemaleCopenhagen Academy for Medical Education and Simu…
NCT07754071 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Able to understand Danish or English. * Able and willing to provide written informed consent. Exclusion Criteria: * Multiple pregnancy. * Fetus in transverse lie. * Inability to provide written informed consent.
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What it tests

  • Not listed
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Where

3 sites
Nordsjællands Hospital, Department of Obstetrics and Gynecology
Hillerød, Denmark
Rigshospitalet - Department of Obstetrics and Gynecology
Copenhagen, Denmark
Slagelse Hospital, Department of Obstetrics and Gynecology
Slagelse, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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