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

NCT07754071 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen Academy for Medical Education and Simulation

Phase

Observational

Started

2025-09-11

Last updated

2026-08-10

Condition(s) studied

PregnancyFetal PresentationBreech Fetal PresentationCephalic Fetal Presentation

Study summary

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

Sex

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation. — During the study ultrasound examination (approximately 5 minutes).
Overall proportion of correct AI predictions of fetal lie and presentation compared with expert clinician assessment (reference standard).

Trial sites (3)

Facility	City	Region	Status
Nordsjællands Hospital, Department of Obstetrics and Gynecology	Hillerød	Capital Region	Not Yet Recruiting
Rigshospitalet - Department of Obstetrics and Gynecology	Copenhagen	København Ø	Recruiting
Slagelse Hospital, Department of Obstetrics and Gynecology	Slagelse	Denmark	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07754071 on ClinicalTrials.gov ↗ ← All trials in Denmark