The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations

NCT ID: NCT06788808

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2026-12-31

Brief Summary

The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.

Detailed Description

During fetal life, the CNS undergoes major changes, so it is important to study the evolution of brain morphology serially during intrauterine life.

Despite numerous data in the literature, prenatal ultrasound diagnosis of CNS malformations is often difficult due to the presence of imaging pictures that are nondiagnostic or difficult to interpret. Moreover, only some of the sonographic features of CNS malformations have been described in detail. Therefore, it is essential to study and describe the ultrasound pictures in order to identify new ultrasound patterns useful to identify the fetal malformation more clearly. Therefore, this study aims to retrospectively analyze the ultrasound images of fetuses with established brain malformations and compare them with those of healthy fetuses in order to highlight the presence of new ultrasound patterns, which may more clearly define the malformative pathology.

Ultrasound images routinely performed in pregnancy in fetuses with brain malformation and in healthy fetuses will be reviewed.

For each patient, information will be collected on:

• Age
• Previous pregnancies and their outcome
• Pregnancy arising spontaneously or through Medically Assisted Procreation techniques
• Family history of congenital malformation
• Type of central nervous system malformation (neural tube defects, holoprosencephaly, corpus callosum agenesis, cerebellar malformations, posterior cranial fossa cysts, other malformations)
• Gestational age at the time of diagnostic suspicion
• Gestational epoch at the time of diagnosis
• Pregnancy outcome (miscarriage, voluntary termination of pregnancy, spontaneous delivery or cesarean section)
• Presence of associated abnormalities affecting other anatomical districts

For each newborn, information will be collected on:

• Sex
• Weight
• Umbilical artery pH
• APGAR index at 5 and 10 minutes
• Neurological assessment in the immediate postpartum period
• Perinatal mortality

Conditions

Malformation Brain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fetus with CNS malformations

Evaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation

Comparison between groups

Intervention Type: OTHER

Ultrasound images acquired during routine ultrasound scans performed in healthy fetuses and in fetuses found to have CNS malformations will be reviewed. Ultrasound images acquired from January 2000 to May 2021 will be analyzed until a sample size of approximately 80 patients is reached, who will be divided into 2 groups: group A (patients whose fetus has CNS malformations) and group B (healthy patients whose fetus has no anatomical CNS abnormalities).

Fetus withous CNS malformations

Evaluation of ultrasound images routinely performed during pregnancy in healthy fetuses

Comparison between groups

Intervention Type: OTHER

Ultrasound images acquired during routine ultrasound scans performed in healthy fetuses and in fetuses found to have CNS malformations will be reviewed. Ultrasound images acquired from January 2000 to May 2021 will be analyzed until a sample size of approximately 80 patients is reached, who will be divided into 2 groups: group A (patients whose fetus has CNS malformations) and group B (healthy patients whose fetus has no anatomical CNS abnormalities).

Interventions

Comparison between groups

Ultrasound images acquired during routine ultrasound scans performed in healthy fetuses and in fetuses found to have CNS malformations will be reviewed. Ultrasound images acquired from January 2000 to May 2021 will be analyzed until a sample size of approximately 80 patients is reached, who will be divided into 2 groups: group A (patients whose fetus has CNS malformations) and group B (healthy patients whose fetus has no anatomical CNS abnormalities).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women older than 18 years with single pregnancy and fetus with ultrasound diagnosis of central nervous system malformation (group A)
• Women with single pregnancy and normoconformed fetuses (group B).

Exclusion Criteria

• Twin pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianluigi Pilu, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianluigi Pilu, MD

Role: CONTACT

gianluigi.pilu@aosp.bo.it

0512143493

Facility Contacts

Gianluigi Pilu, MD

Role: primary

gianluigi.pilu@aosp.bo.it

0512143493

Other Identifiers

CNS_2021

Identifier Type: -

Identifier Source: org_study_id