Fetal Brain Ultrasound

Fetal Anomaly Clinical Trial

Official title:

Fetal Brain Sonographic Measurements and Normograms in Healthy Fetuses During Second and Third Trimesters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410391
• Other study ID #: FBUS
• Status: Recruiting
• Start date: June 15, 2024
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: Mohamed Fekry, PhD
• Phone: 0882312388
• Email: mohamedbeethoven2040[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Also, to determine whether the maternal body mass index (BMI) affects rates of visualized and non-visualized CSP and CC.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant woman 15 weeks to 36 weeks

Exclusion Criteria:

• congenital malformations

• Multiple pregnancy

• intrauterine infection

• fetuses with Fetal growth restriction

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomaly

Intervention

Device:
• Ultrasound
Gestational age, biparietal diameter and head circumference are measured. then 2 techniques are used according to the 2007 International Society of Ultrasound in Obstetrics and Gynecology guidelines for a US evaluation of the fetal central nervous system (CNS) (10) : 1- the axial transventricular technique including the posterior portions of the lateral ventricles, falx, CSP, and Frontal horn 2- the trans-cerebellar technique, including the cerebellum, cisternal magna, cerebellar peduncles, CSP, and FHs. CSP visualization and width, FH width, anterior horn width (AHW), center from the horn distance (CFHD), upside and downside measurement. The corpus callosum is identified in the midsagittal plane. The image selected for CC measurement in addition to cerebellar vermis and cisterna magna

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,	Diameter of Lateral ventricles measured by ultrasound in millimeters	5 months
Secondary	measurement of Cavum septum and Corpus callosum	Length of Cavum septum and Corpus callosum measured by ultrasound in millimeters	5 months