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临床试验/NCT07169929
NCT07169929已完成不适用

The Reliability of Measuring Transverse Thalamic Diameter in Determining the Gestational Age as a Fetal Growth Parameter Using 2D Ultrasound

Cairo University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年9月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Realibity of transverse thalamic diameter as a parameter for fetal growth

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • All pregnant women with singleton pregnancy with gestational age between 18 to 36 weeks

排除标准

  • 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

研究组 & 干预措施

Healthy pregnant women who will meet the inclusion criteria and attend the feto-maternal unit

干预措施: Measurement of fetal transverse thalamic diameter by 2dimensional abdominal ultrasound (Other)

结局指标

主要结局

Realibity of transverse thalamic diameter as a parameter for fetal growth

时间窗: 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)

Realibity of transverse thalamic diameter as a parameter for fetal growth

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Mostafa Mohammed Refaay El shemy

Assistant professor of Obstetrics and Gynecology

Cairo University

研究点 (1)

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