An observational study in Pregnancy, Fetal Presentation and Breech Fetal Presentation, sponsored by Copenhagen Academy for Medical Education and Simulation. Recruiting at 3 sites in Denmark. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Copenhagen Academy for Medical Education and Simulation · Observational
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.
Accurate assessment of fetal lie and presentation during the third trimester is essential for obstetric management and delivery planning. Ultrasound is the gold standard for determining fetal orientation; however, the examination is highly operator-dependent and requires considerable experience to correctly identify fetal anatomy and orientation. Artificial intelligence (AI)-based navigational support systems have the potential to assist clinicians by providing real-time guidance during ultrasound examinations and improving the consistency of fetal orientation assessment.
The purpose of this study is to prospectively validate an AI-based navigational support system for determining fetal lie and presentation during routine third-trimester ultrasound examinations. The system analyzes blind ultrasound sweeps acquired along the maternal midline and automatically predicts fetal lie and presentation. AI-generated predictions will be compared with expert clinician assessment, which serves as the reference standard.
Eligible pregnant women attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse - or Hillerød hospital, will be invited to participate. Following written informed consent, an expert clinician will first determine fetal lie and presentation as part of the routine ultrasound examination. The same clinician will subsequently acquire three blind ultrasound sweeps along the maternal midline. The AI navigational support system will analyze each sweep and generate predictions of fetal lie and presentation. All examinations will be completed within 5-10 minutes to minimize changes in fetal orientation between the clinical assessment and AI evaluation.
The primary objective is to evaluate the diagnostic performance of the AI system by comparing AI-generated predictions with expert clinician assessment. Primary outcome measures include overall diagnostic accuracy and agreement,
These findings will provide additional insight into the feasibility of implementing AI-assisted navigational support in routine obstetric ultrasound practice.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 150 is above the median of 135 across 10 observational studies indexed under Breech Presentation.
Browse Breech Presentation studies →Copenhagen Academy for Medical Education and Simulation is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women with singleton pregnancies attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse Hospital, or Hillerød Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with singleton pregnancies in the third trimester (≥28+0 weeks' gestation) undergoing obstetric ultrasound examination. Participants undergo three blind ultrasound sweeps, and AI-generated predictions of fetal lie and presentation are compared with expert clinician assessment.
Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation.
Overall proportion of correct AI predictions of fetal lie and presentation compared with expert clinician assessment (reference standard).
Time frame: During the study ultrasound examination (approximately 5 minutes).
Agreement between AI predictions and expert clinician assessment.
Agreement will be evaluated using Cohen's kappa coefficient.
Time frame: During the study ultrasound examination.
Plan to share: No — Individual participant data will not be made publicly available because the dataset contains identifiable medical imaging data and is subject to Danish data protection regulations (GDPR).
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Copenhagen Academy for Medical Education and Simulation