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Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 16, 2023

Trial Information

Current as of June 18, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use artificial intelligence (AI) to help detect possible brain problems in unborn babies during the first trimester of pregnancy. The goal is to develop an AI program that can automatically analyze ultrasound images to identify whether the brain structures of the fetus are normal or show signs of abnormalities. This is important because finding these issues early can help in planning the best care for the baby.

To participate in this trial, women must be pregnant with a single baby and have had an ultrasound between 11 and 13 weeks of pregnancy. Participants will undergo a special ultrasound scan that focuses on the fetal brain, which can be challenging due to the small size of the structures and the baby’s movements. The researchers are looking for women who can provide informed consent and who can have clear images taken during the scan. This trial is currently recruiting participants, and it aims to improve how we assess fetal brain health early in pregnancy.

Gender

FEMALE

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.

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, Rm, Italy

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Alessandra Familiari, MD

Principal Investigator

Fondazione Policlinico Agostino Gemelli

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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