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OpenTrials
Completed

NCT Number: NCT06410391

Fetal Brain Ultrasound

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.

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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Women Health Hospital

Asyut, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant woman 15 weeks to 36 weeks

Exclusion criteria

  • congenital malformations
  • Multiple pregnancy
  • intrauterine infection
  • fetuses with Fetal growth restriction

Treatment and study plan

Ultrasound

Radiation

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

Primary outcomes

  1. 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

Secondary outcomes

  1. measurement of Cavum septum and Corpus callosum

    Time frame: 5 months

    Length of Cavum septum and Corpus callosum measured by ultrasound in millimeters

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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