Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester
Recruiting now
Conditions studied: Pregnancy, Fetal Presentation, Breech Fetal Presentation, Cephalic Fetal Presentation
In brief
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.
Key facts
- Study ID
- NCT07754071
- Run by
- Copenhagen Academy for Medical Education and Simulation
- People needed
- 150
- Starts
- 2025-09-11
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Multiple pregnancy.
- Fetus in transverse lie.
- Inability to provide written informed consent.
Where it is running
- Rigshospitalet - Department of Obstetrics and Gynecology — Copenhagen, København Ø, Denmark (enrolling)
- Nordsjællands Hospital, Department of Obstetrics and Gynecology — Hillerød, Capital Region, Denmark
- Slagelse Hospital, Department of Obstetrics and Gynecology — Slagelse, Denmark
Full record on ClinicalTrials.gov
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