- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410391
Fetal Brain Ultrasound
Fetal Brain Sonographic Measurements and Normograms in Healthy Fetuses During Second and Third Trimesters
Study Overview
Detailed Description
Fetal central nervous system (CNS) abnormalities are among the most commonly encountered congenital abnormalities . Many different methods can be used to obtain prenatal diagnoses, including ultrasound (US), which is one of the most commonly used methods .Neonatal survival rates have increased over the last decades leading to increased number of infants with adverse neurodevelopmental outcomes, including cognitive, motor impairments and behavioral and learning difficulties later in life . Recent studies demonstrated that signs of abnormal neurological development are already present at birth .
Frontal horns (FHs) are the most anterior portions of the lateral ventricles, on each side the cavum septi pellucidi (CSP). In accordance with practice parameters released as early as 1985 by the American Institute of Ultrasound in Medicine, American College of Obstetrics and Gynecology, and Society of Radiologists in Ultrasound, the CSP is examined in screening fetal ultrasound (US) examinations in the biparietal diameter view . Frontal horns (FH) are also visualized in the same plane. Abnormal morphologic characteristics of the FHs such as enlargement, squaring, spearing, and splaying may have an association with congenital intracranial anomalies such as holoprosencephaly, schizencephaly and agenesis of the corpus callosum .
The corpus callosum (CC) is the largest interhemispheric white matter commissure of the human brain . It is a sensitive indicator of normal brain development and maturation
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pregnant woman 15 weeks to 36 weeks
Exclusion Criteria:
- congenital malformations
- Multiple pregnancy
- intrauterine infection
- fetuses with Fetal growth restriction
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,
Time Frame: 5 months
|
Diameter of Lateral ventricles measured by ultrasound in millimeters
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of Cavum septum and Corpus callosum
Time Frame: 5 months
|
Length of Cavum septum and Corpus callosum measured by ultrasound in millimeters
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FBUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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