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

NCT07754071 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-08-10

No results posted yet for this 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.

Conditions

  • Pregnancy
  • Fetal Presentation
  • Breech Fetal Presentation
  • Cephalic Fetal Presentation

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen Academy for Medical Education and Simulation

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754071 on ClinicalTrials.gov