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AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan

Recruitingn/aAges 18 Years - 60 YearsFemaleFondazione Policlinico Universitario Agostino Gem…
NCT06675266 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Obstetric ultrasound represents the standard of care for the screening of the fetal anomalies. However, its performance is dependent upon several parameters including type of anomaly, gestational age, maternal habitus and skills of the examiner. The use of Artificial Intelligence (AI) in medical diagnostics has been suggested not only to reduce the inter- and intra-operator variability, but also to compress the required time necessary to perform routine tasks, hence optimizing healthcare resources. Fetal brain abnormalities are among the most challenging fetal congenital anomalies in terms of ultrasound diagnosis, prenatal counseling and management. The access to new sources of technology, i.e. AI, has the potential to improve recognition, detection and localization of brain malformations. Therefore, we propose to develop an AI-based software, which would be capable to recognize the brai

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women with singleton pregnancies undergoing ultrasound examination between 19+0 - 22+6 weeks of gestation Exclusion Criteria: * Women who did not have the second trimester screening scan at the settled gestational age. * Women in which a good visualization of the transventricular, transthalamic and transcerebellar plane of the fetal head was not technically possible. * Women who are not able to give the informed consent.
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What it tests

  • Development of AI algorithm for early detection of fetal brain anomalies in the second trimester screening scan
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Where

1 site
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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