Pregnancy ComplicationsNCT06314178
Comparing Artificial Intelligence and Standard Ultrasound Methods for Estimating Fetal Weight in Pregnancy. Patients Eligible for Inclusion Are Women With a Gestational Age Between 24-42 Weeks Undergoing a Growth Scan. The Image Data From the Scan Are Used to Calculate Fetal Weight.
An observational study of Pregnancy Complications, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial summary
The primary aim of this observational study is to compare the accuracy of two artificial intelligence (AI) models with the traditional Hadlock formula for estimating fetal weight from ultrasound scans performed in pregnant women between 24 and 42 weeks of gestation. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- How many people
- 283 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2024to 30 Dec 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Department of Prenatal Examinations at Rigshospitalet, Copenhagen, Denmark.
Who may be able to join
- Women with gestational age between 24-42 weeks undergoing a third-trimester growth scan.
Who cannot join
- Women with multiple pregnancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Silent Trial of Artificial Intelligence for Fetal Weight Estimation
The primary aim of this observational study is to compare the accuracy of two artificial intelligence (AI) models with the traditional Hadlock formula for estimating fetal weight from ultrasound scans performed in pregnant women between 24 and 42 weeks of gestation. The secondary aim is to investigate potential demographic bias in the AI models. The demographic factors examined include body mass index (BMI), parity, gestational age, maternal age, fetal sex, and the presence of preeclampsia.
Participants' ultrasound scans will be pseudonymized and securely stored on password-protected removable drives to ensure the protection of their identity and privacy. The ultrasound data will subsequently be transferred to the Technical University of Denmark (DTU), where the AI models will analyze the images to estimate fetal weight.
- Conditions
- Pregnancy Complications
- Medical subject headings
- Pregnancy Complications
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 |
|---|---|---|
| Pregnant women between 24-42 weeks of gestation | No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the accuracy of the Hadlock formula and the AI model
The primary objective is to compare the accuracy of fetal weight estimation between the Hadlock formula and two deep learning models in clinical practice
Measured: From enrollment to the birth of the child
Secondary outcomes (1)
Demographic biases
The secondary objective is to investigate whether the deep learning models show any demographic biases when estimating fetal growth in clinical practice. This is assessed by comparing the accuracy of the Hadlock formula and the deep learning models against the fetal weight at the time of the scan, which is estimated from the birth weight using the Marsal growth curve.
Measured: From enrollment to the birth of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Leth-Petersen, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314178
- Sponsor's protocol ID
- p-2024-15469
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salomon LJ, Alfirevic Z, Da Silva Costa F, Deter RL, Figueras F, Ghi T, Glanc P, Khalil A, Lee W, Napolitano R, Papageorghiou A, Sotiriadis A, Stirnemann J, Toi A, Yeo G. ISUOG Practice Guidelines: ultrasound assessment of fetal biometry and growth. Ultrasound Obstet Gynecol. 2019 Jun;53(6):715-723. doi: 10.1002/uog.20272.
PubMed 31169958
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Silent Trial of Artificial Intelligence for Fetal Weight Estimation
- ClinicalTrials.gov ID
- NCT06314178
- Acronym / sponsor ID
- p-2024-15469
- Conditions
- Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Mar 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.
The primary aim of this observational study is to compare the accuracy of two artificial intelligence (AI) models with the traditional Hadlock formula for estimating fetal weight from ultrasound scans performed in pregnant women between 24 and 42 weeks of gestation. The secondary aim is to investigate potential demographic bias in the AI models. The demographic factors examined include body mass index (BMI), parity, gestational age, maternal age, fetal sex, and the presence of preeclampsia.
Participants' ultrasound scans will be pseudonymized and securely stored on password-protected removable drives to ensure the protection of their identity and privacy. The ultrasound data will subsequently be transferred to the Technical University of Denmark (DTU), where the AI models will analyze the images to estimate fetal weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women between 24-42 weeks of gestation | – | –No interventions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Department of Prenatal Examinations at Rigshospitalet, Copenhagen, Denmark.
Key inclusion criteria (1 listed)
- Women with gestational age between 24-42 weeks undergoing a third-trimester growth scan.
Key exclusion criteria (1 listed)
- Women with multiple pregnancies.
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
Comparing the accuracy of the Hadlock formula and the AI model
Time frame: From enrollment to the birth of the child
The primary objective is to compare the accuracy of fetal weight estimation between the Hadlock formula and two deep learning models in clinical practice
1 secondary outcome
Demographic biases
Time frame: From enrollment to the birth of the child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 31169958Salomon LJ, Alfirevic Z, Da Silva Costa F, Deter RL, Figueras F, Ghi T, Glanc P, Khalil A, Lee W, Napolitano R, Papageorghiou A, Sotiriadis A, Stirnemann J, Toi A, Yeo G. ISUOG Practice Guidelines: ultrasound assessment of fetal biometry and growth. Ultrasound Obstet Gynecol. 2019 Jun;53(6):715-723. doi: 10.1002/uog.20272.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications, run by Copenhagen Academy for Medical Education and Simulation at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the accuracy of the Hadlock formula and the AI model (time frame: From enrollment to the birth of the child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314178, which also lists 1 linked publication.
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 12 Jun 2026.