- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07169929
- Original Trial
Fetal Transverse Thalamic Diameter and Assessment of Gestational Age as a Fetal Growth Parameter Using 2D Ultrasound
The Reliability of Measuring Transverse Thalamic Diameter in Determining the Gestational Age as a Fetal Growth Parameter Using 2D Ultrasound
The thalamus is a nuclear complex which located in the diencephalon of the brain. Its main function is to relay messages which affect the sensory and motor functions in the body. A lot of behavioral functions are accredited to it such as memory, learning, attention and language. (Sridar P,et al 2020) There is an automatic thalamic diameter measurement to estimate the thalamic diameter, with the measurement accuracy as good as the clinical assessment.( Sridar P,et al 2016) Transverse thalamic diameter increased significantly with increasing gestational age, head circumference, and trans-cerebellar diameter linearly, and normal range thalamic charts are presented. The guitar shape provided good reproducibility of thalamic diameter measures. (Sridar P,et al 2020) Also the evaluation of echogenic thalamus is beneficial, and can be considered as a new marker of fetal lung maturity. ( Rasheed FA, et al 2012).
Maternal hyperglycemia was significantly associated with an increase in the widths of fetal posterior lateral ventricles, cavum septum pellucidi, and cisterna magna and a decrease in fetal trans-cerebellar diameter with no difference was found between three groups in terms of fetal thalamus size (Ekin A. et al 2023).
However, little is known about the growth pattern of thalami during fetal life, and virtually nothing is known about the possible association of deviations from the normal growth pattern with the abnormal conditions. There is a study published on fetal thalami which compare the volumes of cerebral structures, including thalami, between two group's normally growing and growth-restricted fetuses and reported lack of significant difference in thalamic volumes between the two groups. (Elshal RS.etal 2023).
During fetal life, the thalamus increases in size between the ages of 20 to 43 weeks of gestation (Tutunji R et al 2018 ) The development of the thalamus is not a unified progress as it shows remarkable dynamism and heterogeneity ( Zheng et al., 2023) For example, before 35 weeks post-menstrual age ,morphological changes were relatively uniform across the thalamus, and after 35 weeks post menstrual age, deformation was more obvious at the rim than in the central part of the thalamus (Liu et al., 2021).
Prospective research ensures focused attention to the structures to be measured, with more clearly imaged by the operator and using variable contrast resolution to ensuring clarity of the measured structure and prevent any artefacts which prevent visualization. .( Sridar P etal 2020) While Ultrasound allows the measurement of the fetal brain in real time and has fewer artefacts from the movement of the fetus, it is operator dependent. (Bookstein S etal 2024).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Cairo Governorate
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Giza, Cairo Governorate, Egypt, 4240310
- Shaimaa El Shemy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All pregnant women with singleton pregnancy with gestational age between 18 to 36 weeks
Exclusion Criteria:
- Women who are not sure of dates and don't have an US report with CRL measured in the first trimester
- Maternal obesity (BMI>35) as abdominal fat cause restriction in taking measurement
- Known case of DM or Hypertension or SLE
- Any fetal head or CNS anomalies
- Any maternal opiates and CNS drugs (methadone) IUGR
- Twins or multiple pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy pregnant women who will meet the inclusion criteria and attend the feto-maternal unit
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All pregnant women attending the feto-maternal unit with gestational age from 18 weeks to 36 weeks in the obstetrics and gynecology department in the faculty of medicine Cairo university Using curvilinear 2D transabdominal ultrasound probe of ultrasound machine either Voluson E10 GE or Nuewa I9 Elite Mindray. The investigators will take all the biometry (Biparietal diameter, head circumference, abdominal circumference, femur length and trans-cerebellar diameter) and exclude any congenital anomalies in the scan. Transverse thalamic diameter is to be measured by 2D ultrasound at the standard axial trans-cerebellar plane. A guitar shape representative structure is presented to demarcate the thalamic diameter. Calculate the gestational age using transverse thalamic diameter from this equation Transverse thalamic Diameter( in mm)=0.912 x Gestational age in weeks -1.134) ( Sridar P, et al 2020) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Realibity of transverse thalamic diameter as a parameter for fetal growth
Time Frame: 6months
|
Correlation of measuring the transverse thalamic diameter in determining the gestational age between 18 weeks and 36 weeks according to this equation (Transverse thalamic Diameter( in mm)=0.912
x Gestational age in weeks -1.134) ( Sridar P, et al 2020)
|
6months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- Transverse thalamic diameter
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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