Status:
RECRUITING
AIRFRAME: Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs at Second Trimester Fetal Brain Scan
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Ospedale Di Venere - Carbonara di Bari - Bari, Italy
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Fetal Anomalies
Brain Malformation
Eligibility:
FEMALE
18-60 years
Brief Summary
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,...
Detailed Description
The application of AI in obstetric ultrasound includes three aspects: structure identification, automatic and standardized measurements, and classification diagnosis. Since obstetric ultrasound is tim...
Eligibility Criteria
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.
Key Trial Info
Start Date :
April 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06675266
Start Date
April 30 2023
End Date
December 30 2026
Last Update
November 5 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy, 00136