Actively Recruiting

Age: 18Years - 60Years
FEMALE
Healthy Volunteers
NCT06675266

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-11-05

10000

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

O

Ospedale Di Venere - Carbonara di Bari - Bari, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 brain structures at antenatal ultrasound and discriminate between normal and abnormal fetal brain anatomy through fully automatic data processing.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with singleton pregnancies undergoing ultrasound examination between 19+0 and 22+6 weeks of gestation
Not Eligible

You will not qualify if you...

  • Women who did not have the second trimester screening scan at the specified gestational age
  • Women in whom good visualization of the transventricular, transthalamic, and transcerebellar planes of the fetal head was not technically possible
  • Women who are unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy, 00136

Actively Recruiting

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Research Team

A

Alessandra Familiari, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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