Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum

NCT ID: NCT06782802

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2026-12-31

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.

Conditions

Fetal Neurodevelopmental Disorder; Cavum Septum Pellucidum

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Pregnant participants with a diagnosis of cavum septum pellucidum obliteration made at second-trimester morphologic ultrasound between 19+0 and 21+6 weeks
• Age > or = 18 years at the time of outpatient access
• Acquisition of informed consent form, from the patient and minor
• Patients followed at our center

Exclusion Criteria

• None

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 44 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

CSP21

Identifier Type: -

Identifier Source: org_study_id