The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations (CNS_2021)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gianluigi Pilu, MD
- Phone Number: 0512143493
- Email: gianluigi.pilu@aosp.bo.it
Study Locations
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-
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Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Contact:
- Gianluigi Pilu, MD
- Phone Number: 0512143493
- Email: gianluigi.pilu@aosp.bo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fetus with CNS malformations
Evaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between new ultrasound patterns and fetal CNS malformations
Time Frame: up to 100 weeks
|
Retrospectively analyze ultrasound images of fetuses with established brain malformations
|
up to 100 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of ultrasound patterns found in fetuses with and without CNS malformations
Time Frame: up to 100 weeks
|
Comparison of ultrasound scans of fetuses with and without CNS malformation to discover of new ultrasound patterns, which may more clearly define the malformative pathology.
|
up to 100 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gianluigi Pilu, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNS_2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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