AI-assisted ultrasound to determine fetal lie and presentation in the third trimester
Official title: Clinical Validation of an Artificial Intelligence System for Determining Fetal Lie and Position in 3rd Trimester
Run by Copenhagen Academy for Medical Education and Simulation · NCT07754071 · Data updated 2026-11-12
Researchers test an AI-based navigation system that helps clinicians determine fetal lie and presentation during third-trimester ultrasounds, by comparing AI predictions to expert assessments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Copenhagen Academy for Medical Education and Simulation Academic / other |
| Locations | 3 sites (Hillerød, Capital Region and 2 other locations) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07754071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 or older with singleton pregnancies at 28+0 weeks’ gestation, where the fetus is in longitudinal lie (cephalic or breech) on routine ultrasound, who can understand Danish or English and provide consent.
✕Probably not a fit
Women with multiple pregnancy, transverse lie, or those who cannot provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study validates an AI-based navigational support system for determining fetal lie and presentation during routine third-trimester ultrasounds. Three blind ultrasound sweeps are performed per participant, and the AI predictions are compared with the expert clinician’s assessment as the reference standard. The study also explores clinician usability and perceived clinical value of the AI tool. Participants are pregnant women at 28 weeks or later with singleton pregnancies undergoing standard third-trimester ultrasound at participating Danish centers. The analysis focuses on diagnostic concordance and potential workflow impact of AI-assisted guidance.
Why it matters
Potential benefit: If successful, the AI system could improve consistency and speed in identifying fetal lie and presentation during late-pregnancy ultrasound.
How similar studies have gone: Previous studies in AI-assisted ultrasound have shown promise in improving image interpretation and consistency, but prospective validation in third-trimester fetal orientation is still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Rigshospitalet - Department of Obstetrics and Gynecology
Copenhagen, København Ø, Denmark Recruiting -
Nordsjællands Hospital, Department of Obstetrics and Gynecology
Hillerød, Capital Region, Denmark Not yet recruiting -
Slagelse Hospital, Department of Obstetrics and Gynecology
Slagelse, Denmark Not yet recruiting
Study contacts
- Study coordinator: Mary Le Ngo, MD, MD
- Email: mary.van.anh.le.ngo.01@regionh.dk
- Phone: +45 20773779
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.