Actively Recruiting

Age: 28Days - 44Years
FEMALE
ID06782802

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

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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

Age: 28Days - 44Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

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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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