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NCT06314178
Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice. Patients Eligible for Inclusion Are Women with a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan. the Image Data from the Scan Are Used to Calculate Fetal Weight.
trial in Pregnancy Complications in 185 participants. Completed in 30 November 2024.
30 August 2024
Quick facts
| Lead sponsor | Copenhagen Academy for Medical Education and Simulation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 185 |
| Start date | 1 July 2024 |
| Primary completion | 30 August 2024 |
| Estimated completion | 30 November 2024 |
| Sites | 1 location across Denmark |
Conditions studied
- Pregnancy Complications — all drugs for Pregnancy Complications →
Sponsor
Copenhagen Academy for Medical Education and Simulation
Who can join
Eligibility, female only, with Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to compare a new artificial intelligence (AI) feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation. The study aims to investigate the presence of demographic bias in the AI model. The demographic factors examined in the study include Body Mass Index (BMI), the number of births, fetal age, mother\'s age, fetal sex, and the presence of preeclampsia. Moreover, the study will compare the accuracy of the AI model and the Hadlock model, a fetal growth formula, in estimating fetal weight. Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives, ensuring their identity and privacy are maintained. Afterward, the ultrasound data will be sent to the Technical University of Denmark (DTU), where the AI model will analyze the images to estimate fetal weight.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06314178
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06314178 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Copenhagen Academy for Medical Education and Simulation
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06314178.
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