The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comparison between groups.
- Who it may be relevant to
- Registry conditions: Malformation Brain. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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).
Primary outcome measures
- Correlation between new ultrasound patterns and fetal CNS malformations [Time frame: up to 100 weeks]
Secondary outcome measures (1)
- Comparison of ultrasound patterns found in fetuses with and without CNS malformations [Time frame: up to 100 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06788808 · CNS_2021