跳至主要内容
临床试验/NCT05771922
NCT05771922招募中不适用

Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY

研究概览

简要总结

The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

详细描述

The neural system malformation is one of the more common congenital anomalies encountered in pregnancy. They represent about 0.3-1 percent of all live births. During a prenatal anomaly scan, detection of CNS malformations is important, especially since these anomalies have a poor prognosis and are also associated with genetic syndromes or chromosomal anomalies. Such malformations have clinical importance because they are associated with high rates of morbidity and mortality, influencing the neurocognitive and motor development of the survivors, who may have lifelong sequelae. Thus, it's extremely important to assess the fetal CNS during the prenatal period in order to identify any changes in its development and give appropriate advice to parents regarding pregnancy follow-up. Also, it is vital to explore options for fetal therapy and the timing/type of delivery, as well as postnatal treatment and prognosis.

The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 28 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Suspicion of CNS or spinal malformation at routine screening ultrasound Suspicion of CNS or spinal malformation at nuchal translucency scan Family history of inheritable CNS spinal malformations Previous pregnancy complicated by fetal brain or spinal malformation Fetus with congenital heart disease Monochorionic twins Suspected congenital intrauterine infection Exposure to teratogens known to affect neurogenesis

排除标准

  • Low risk pregnancy

结局指标

主要结局

PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY

时间窗: 2 years

tO DETECT PREVELANCE OF FETAL BRAIN CONGENITAL ANOMALIES UTILIZING STANDARD THREE-AXIAL VIEW (TRANSTHALAMIC, TRANSVENTRICULAR AND TRANSCEREBELLER ) WITH 2D ULTRASONOGRAPHY

PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .

时间窗: 2 years

PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY BY SURFACE 3 D, MULTIPLANNER AND MULTISLICE VIEWS .

PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY

时间窗: 2 years

PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS (TRANCALVERIAL AND TRANSGENU AND SPELNIUM) TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Atef Darwish

Senior consultant of Obstetrics and Gynecology

Woman's Health University Hospital, Egypt

研究点 (1)

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