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Search / Trial NCT06675266

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Nov 4, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Fetal Brain Anomaly Brain Malformation Second Trimester Ultrasound Scan

ClinConnect Summary

The AIRFRAME trial is studying the use of Artificial Intelligence (AI) to improve the detection of brain abnormalities in unborn babies during routine ultrasound exams. This research aims to create a special software that can automatically recognize normal and abnormal brain structures in the fetus, making it easier for doctors to identify issues that may need further attention. This is particularly important because diagnosing fetal brain problems can be challenging, and the use of AI could enhance the accuracy and efficiency of these screenings.

To participate in this trial, women must be pregnant with a single baby and have an ultrasound scheduled between 19 to 22 weeks of pregnancy. Unfortunately, women who cannot have a clear view of the baby's brain structures during the ultrasound or who cannot provide informed consent will not be eligible. Those who join the study can expect to undergo the usual ultrasound examination, with the added benefit of AI assistance to help identify any potential brain anomalies more effectively. This trial is currently recruiting participants, and it represents an exciting opportunity to improve prenatal care for mothers and their babies.

Gender

FEMALE

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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Alessandra Familiari

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported