Status:
UNKNOWN
Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Ministero della Salute, Italy
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Fetal Anomaly
Brain Malformation
Eligibility:
FEMALE
18-45 years
Brief Summary
Visualization of the posterior fossa brain spaces, their spatial relationship and measurements can be obtained in the midsagittal view of fetal head, the same used for NT measurement (9), and plays an...
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 single pregnancies who underwent ultrasound examination between 11+0 - 13+6 weeks of gestation or a fetal crown-rump-length between 45 - 84 mm.
Exclusion Criteria:
- Women who did not have the first trimester screening scan at the settled gestational age.
- Women in which a good visualization of the mid-sagittal view of the fetal head was not technically possible.
- Women who are not able to give the informed consent.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT05790473
Start Date
May 1 2023
End Date
May 1 2025
Last Update
March 22 2024
Active Locations (1)
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1
FP Gemelli IRCCS
Rome, Italy, 00168