PregnancyNCT07754071
Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester
An observational study of Pregnancy and Fetal Presentation, run by Copenhagen Academy for Medical Education and Simulation at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pregnancy, Fetal Presentation, Breech Fetal Presentation
- How many people
- 150 participants
- Where
- 3 sitesDenmark
- Study dates
- 11 Sep 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with singleton pregnancies attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse Hospital, or Hillerød Hospital.
Who may be able to join
- 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.
Who cannot join
- Multiple pregnancy.
- Fetus in transverse lie.
- Inability to provide written informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Rigshospitalet - Department of Obstetrics and Gynecology
Copenhagen, København Ø, 2100
Martin Tolsgaard, professor,, Medical doctor, Ph.D, +4520773779, martin.groennebaek.tolsgaard@regionh.dk
- Not yet recruiting
Nordsjællands Hospital, Department of Obstetrics and Gynecology
Hillerød, Capital Region, 3400
Gitte Hedermann, Associate Professor, +2520773779, gitte.hedermann.christensen@regionh.dk
- Not yet recruiting
Slagelse Hospital, Department of Obstetrics and Gynecology
Slagelse, 3450
Kathinka Nyborg, MD, 20773779, kany@regionsjaelland.dk
About this study
Official title: Clinical Validation of an Artificial Intelligence System for Determining Fetal Lie and Position in 3rd Trimester
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.
Read the detailed description
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.
- Keywords
- fetal lie, fetal presentation, obstetric ultrasound, artificial intelligence, AI-assisted ultrasound, Navigation system, blind ultrasound sweep, third trimester pregnancy, clinical validation, Diagnostic accuracy, fetal orientation
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Clinical Validation Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the study ultrasound examination (approximately 5 minutes).
Secondary outcomes (1)
Agreement between AI predictions and expert clinician assessment.
Agreement will be evaluated using Cohen's kappa coefficient.
Measured: During the study ultrasound examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start11 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Mary Le Ngo, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754071
- Sponsor's protocol ID
- P-2019-3101
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of an Artificial Intelligence System for Determining Fetal Lie and Position in 3rd Trimester
- ClinicalTrials.gov ID
- NCT07754071
- Acronym / sponsor ID
- P-2019-3101
- Keywords
- fetal lie, fetal presentation, obstetric ultrasound, artificial intelligence, AI-assisted ultrasound, Navigation system, blind ultrasound sweep, third trimester pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Clinical Validation Cohort | – | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with singleton pregnancies attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse Hospital, or Hillerød Hospital.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Multiple pregnancy.
- Fetus in transverse lie.
- Inability to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation.
Time frame: 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).
1 secondary outcome
Agreement between AI predictions and expert clinician assessment.
Time frame: During the study ultrasound examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Fetal Presentation, run by Copenhagen Academy for Medical Education and Simulation at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Le Ngo, MD, MD (+45 20773779, mary.van.anh.le.ngo.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation. (time frame: During the study ultrasound examination (approximately 5 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.