跳至主要内容
临床试验/NCT03888794
NCT03888794Unknown不适用

Magnetic Resonance Imaging Versus Four Dimensional Ultrasound in Detection of Central Nervous System Fetal Congenital Anomalies

Assiut University0 个研究点目标入组 50 人开始时间: 2019年5月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Ventricular size

研究概览

简要总结

Congenital central nervous system (CNS) anomalies are common and most devastating. They occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.They account for 40% of deaths of all infants in the first year of life. In survivors, they cause a variety of neurological disorders, mental retardation or drug resistant epilepsy.

CNS anomalies are usually compatible with life, prolonged hospitalization, higher health care costs, uncertain future life quality and significant burden to families and society.

详细描述

Early detection of congenital CNS anomalies gives time available for the clinician and parents to plan about the outcome of pregnancy.

Prenatal ultrasound has been well established for decades as the primary technique for evaluating the developing fetus in normal as well as in high risk cases. Advantages of US include widespread availability, relatively low cost and quick, lack of harmful effect to fetus or mother and real time imaging.

Although ultrasound can characterize many anomalies accurately, it has many limitations as operator dependent, small field of view, and relatively poor soft-tissue contrast, beam attenuation by maternal adipose tissue and fetal bone, limited visualization of posterior fossa after 33 weeks gestation because of calvarial calcification. Also, ultrasound relies heavily on fetal positioning and presence of sufficient amniotic fluid to provide an adequate acoustic window fetus So, US findings are occasionally incomplete or inconclusive to guide treatment choices.

Fetal brain MRI became embraced as a clinically important imaging technique useful for fetal assessment, which is helpful in formulating prognosis and perinatal management and can detect occult abnormalities in up to 50% of cases for certain indications.

It can overcome many of ultrasound limitations as it is not limited by maternal obesity, fetal position, or oligohydramnios. Additionally, it has better soft tissue contrast resolution, as well as the ability to distinguish individual fetal structures such as brain, lung, liver, kidney, and bowel. In addition, visualization of the brain is not restricted by the ossified skull. Moreover, MRI provides multiplanar imaging as well a larger field of view, facilitating examination of fetuses with large or complex anomalies.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis).
  • Pregnant females with past or family history of congenital fetal abnormality.

排除标准

  • Pregnancies with normal antenatal US.
  • pregnancies in first trimester
  • Claustrophobic patients.
  • contraindication to MRI as cochlear implants and pacemakers.

结局指标

主要结局

Ventricular size

时间窗: baseline

assess the ventricular size by measuring the anteroposterior diameter of the fourth ventricle, the width of the third ventricle, and the transverse diameter of the lateral ventricles on the coronal images.

次要结局

  • Correlate MRI findings with Ultrasound findings.(baseline)

研究者

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

Nehal Kamal Mohamed

principal Investigator

Assiut University

相似试验

MRI Versus Four Dimensional Ultrasound in Detection... | 临床试验