Fetal Growth RetardationNCT06268392
A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound
An observational study of Fetal Growth Retardation and Fetal Macrosomia, run by Copenhagen Academy for Medical Education and Simulation.
Trial summary
This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Fetal Macrosomia, Fetal Growth
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical students are recruited from the Medical universities in Denmark (mainly Copenhagen University) Pregnant women are chosen from the fetal medical departement at Rigshospitalet, Copenhagen.
Who may be able to join
- Singelton pregnant.
- Gestational age: 30-38 weeks
- Maternal age < 40 years
Who cannot join
- Oligo hydramnion
- Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
- Severe fetal macrosomia or growth restriction.
Trial locations and contacts
No sites are listed yet.
About this study
This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.
Read the detailed description
The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.
From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.
In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .
- Conditions
- Fetal Growth Retardation, Fetal Macrosomia, Fetal Growth
- Keywords
- Artificial Intelligence, Fetal weight estimation, Ultrasound
- Medical subject headings
- Fetal Growth Retardation, Fetal Macrosomia
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 |
|---|---|---|
| Expert sonographer | Expert sonographers ultrasound examination. | |
| Control Group (CG) | Control group ultrasound examination with no AI support. | |
| Feedback group 1 (FG1) | Feedback group 1 ultrasound examination with basic black box AI support. | |
| Feedback group 2 (FG2) | Feedback group 2 ultrasound examination with detailed explainable AI support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal weight
Estimation of fetal weight, generated from AI analysis of fetal ultrasound images.
Measured: 10 minutes
Ultrasound fetal weight estimation
Estimation of fetal weight, calculated from hadlock formula with information from the three standard planes of the head, abdomen and femur.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Hospital, Technical University of Denmark, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Mary Le Ngo, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Martin Tolsgaard, Study director, CAMES rigshopsitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268392
- Sponsor's protocol ID
- CT-2023-11-20-001
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound
- ClinicalTrials.gov ID
- NCT06268392
- Acronym / sponsor ID
- CT-2023-11-20-001
- Conditions
- Fetal Growth Retardation, Fetal Macrosomia, Fetal Growth
- Keywords
- Artificial Intelligence, Fetal weight estimation, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Collaborators
- Slagelse Hospital, Technical University of Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Feb 2024 (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 study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.
Detailed description
The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.
From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.
In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expert sonographer | – | –Expert sonographers ultrasound examination. |
| Control Group (CG) | – | –Control group ultrasound examination with no AI support. |
| Feedback group 1 (FG1) | – | –Feedback group 1 ultrasound examination with basic black box AI support. |
| Feedback group 2 (FG2) | – | –Feedback group 2 ultrasound examination with detailed explainable AI support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical students are recruited from the Medical universities in Denmark (mainly Copenhagen University) Pregnant women are chosen from the fetal medical departement at Rigshospitalet, Copenhagen.
Key inclusion criteria (3 listed)
- Singelton pregnant.
- Gestational age: 30-38 weeks
- Maternal age < 40 years
Key exclusion criteria (3 listed)
- Oligo hydramnion
- Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
- Severe fetal macrosomia or growth restriction.
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
Fetal weight
Time frame: 10 minutes
Estimation of fetal weight, generated from AI analysis of fetal ultrasound images.
Ultrasound fetal weight estimation
Time frame: 15 minutes
Estimation of fetal weight, calculated from hadlock formula with information from the three standard planes of the head, abdomen and femur.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Martin Tolsgaard study director
CAMES rigshopsitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation and Fetal Macrosomia, run by Copenhagen Academy for Medical Education and Simulation.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary L Ngo (+4520773779, mary.van.anh.le.ngo@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal weight (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 22 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.