Actively Recruiting
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum An Observational Study on Fetal Brain Abnormalities and Neurological Outcomes
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-20
15
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration during the second-trimester ultrasound, and to study the postnatal neurological outcomes of these children. The prognosis of isolated CSP obliteration with otherwise normal brain anatomy remains uncertain, and the study investigates this condition's clinical significance and developmental impact. Patients diagnosed with CSP obliteration between 19 and 21 weeks of pregnancy are typically offered fetal brain MRI to identify any associated brain abnormalities more accurately than ultrasound. If CSP obliteration is isolated, monthly ultrasound monitoring is conducted along with a second MRI around 30 to 32 weeks to check for further developmental changes. After birth, children usually receive specialized pediatric evaluations to monitor their neurodevelopment. The study involves analyzing clinical data collected from ultrasounds, neurosonography, and MRIs performed during pregnancy. Researchers will also contact families for a psychiatric assessment of the child at the department of child neuropsychiatry, where age-appropriate neurodevelopmental tests will be administered. If families decline this visit, only prenatal data will be analyzed. The primary outcome measured is the incidence of brain abnormalities detected during the second-trimester ultrasound.
CONDITIONS
Official Title
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant participants diagnosed with cavum septum pellucidum obliteration at second-trimester ultrasound between 19+0 and 21+6 weeks
- Age 18 years or older at outpatient visit
- Provided informed consent
- Patients followed at the study center
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
G
Gianluigi Pilu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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