Evaluating the significance of prenatal diagnosis of cavum septum pellucidum obliteration
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
This study is trying to see if babies diagnosed with a specific brain condition during pregnancy have other problems and how it affects their development after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 28 Days to 44 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06782802 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration during second-trimester ultrasounds. It will analyze the postnatal neurological outcomes of these cases, particularly focusing on the relationship between CSP obliteration and associated brain malformations. Patients will be monitored through monthly ultrasounds and follow-up MRIs to detect any further developmental issues. The study will retrospectively review clinical data from patients diagnosed with CSP obliteration at a specific medical center.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals diagnosed with CSP obliteration during second-trimester ultrasounds between 19+0 and 21+6 weeks.
Not a fit: Patients without a diagnosis of CSP obliteration or those not followed at the participating center may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve prenatal counseling and management for pregnancies affected by CSP obliteration.
How similar studies have performed: While the approach of using MRI for prenatal diagnosis is established, the specific focus on CSP obliteration and its prognostic implications is less commonly studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluigi Pilu, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Gianluigi Pilu, MD
- Email: gianluigi.pilu@aosp.bo.it
- Phone: 0512143493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.