Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-10 @ 4:15 AM
Study NCT ID:
NCT06782802
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well as to analyze the postnatal neurological outcome.
Detailed Description:
In cases of failure to visualize the CSP (obliterated or absent) and additional brain anatomical abnormalities, the feto-neonatal prognosis turns out to be mainly related to the type of associated malformation. It is still debated, however, the prognosis of an absent or isolated obliteration of the SPC in the presence of remaining regular brain anatomy for the time.
Very often, the patient is offered fetal brain MRI, which, compared with ultrasonography, appears to be endowed with greater accuracy in identifying any additional associated cerebral animals. In our center, it is a shared custom to routinely offer the patient the option of performing an MRI, in all cases of failure to visualize the SPC.
If obliteration of the CSP is confirmed as isolated, normal clinical practice is to perform monthly ultrasound monitoring and a second MRI at approximately 30 to 32 weeks, with the aim of ruling out the appearance of further developmental abnormalities. In addition, a specialized pediatric evaluation is usually performed after birth with the aim of following the child developmentally.
In a retrospective manner, clinical data of patients followed at our center from 01/01/2024 to 31/05/2021, with a finding of obliteration of the CSP at the second trimester, will be considered. Of these patients, data from the morphologic ultrasound and concomitant neurosonography and subsequent MRI (if performed) will be analyzed, as well as those that emerged during follow-ups performed until the end of pregnancy. For the purpose of assessing the fetal neurological outcome, such patients will be contacted by telephone, the study will be explained to them, and a proposal will be made for a psychiatric examination at the department of child neuropsychiatry for their child. During this visit the child will be administered psycho-aptitude tests routinely used, according to normal clinical practice, in neurodevelopmental assessment, in accordance with the child's age.
If the patients do not agree to have their children undergo this visit, only the analysis of the data collected during the visits, performed during pregnancy, will be done.
Very often, the patient is offered fetal brain MRI, which, compared with ultrasonography, appears to be endowed with greater accuracy in identifying any additional associated cerebral animals. In our center, it is a shared custom to routinely offer the patient the option of performing an MRI, in all cases of failure to visualize the SPC.
If obliteration of the CSP is confirmed as isolated, normal clinical practice is to perform monthly ultrasound monitoring and a second MRI at approximately 30 to 32 weeks, with the aim of ruling out the appearance of further developmental abnormalities. In addition, a specialized pediatric evaluation is usually performed after birth with the aim of following the child developmentally.
In a retrospective manner, clinical data of patients followed at our center from 01/01/2024 to 31/05/2021, with a finding of obliteration of the CSP at the second trimester, will be considered. Of these patients, data from the morphologic ultrasound and concomitant neurosonography and subsequent MRI (if performed) will be analyzed, as well as those that emerged during follow-ups performed until the end of pregnancy. For the purpose of assessing the fetal neurological outcome, such patients will be contacted by telephone, the study will be explained to them, and a proposal will be made for a psychiatric examination at the department of child neuropsychiatry for their child. During this visit the child will be administered psycho-aptitude tests routinely used, according to normal clinical practice, in neurodevelopmental assessment, in accordance with the child's age.
If the patients do not agree to have their children undergo this visit, only the analysis of the data collected during the visits, performed during pregnancy, will be done.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: