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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06788808
Acronym
CNS_2021
Enrollment
80
Registered
2025-01-23
Start date
2021-10-11
Completion date
2026-12-31
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malformation Brain

Keywords

Prenatal ultrasounds

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

Interventions

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).

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between new ultrasound patterns and fetal CNS malformationsup to 100 weeksRetrospectively analyze ultrasound images of fetuses with established brain malformations

Secondary

MeasureTime frameDescription
Comparison of ultrasound patterns found in fetuses with and without CNS malformationsup to 100 weeksComparison of ultrasound scans of fetuses with and without CNS malformation to discover of new ultrasound patterns, which may more clearly define the malformative pathology.

Countries

Italy

Contacts

Primary ContactGianluigi Pilu, MD
gianluigi.pilu@aosp.bo.it0512143493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026