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

NCT06782802 | Recruiting

• 1 other identifier: CSP21
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Neurodevelopmental Disorder; Cavum Septum Pellucidum

Keywords

Cavum septum pellucidum

Outcome Measures

Primary Outcomes (1)

• Assessment of the incidence of brain abnormalities

  Evaluation of the incidence of associated brain abnormalities, diagnosed by neurosonography and MRI, both at the time of diagnosis and found at subsequent planned follow-ups until the end of pregnancy in fetuses with a finding of obliteration of the cavum septum pellucidum

  During second-trimester ultrasound

Eligibility Criteria

• Age: 28 Days - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants followed at our center between 01/01/2014 and 31/05/2021 with a morphologic ultrasound showing an obliteration of the cavum septum pellucidum will be recruited.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluigi Pilu, MD

CONTACT

0512143493; gianluigi.pilu@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 20, 2025
• Study Start: March 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

IT (1)