跳至主要内容
临床试验/NCT05717855
NCT05717855已完成不适用

Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Calculation of average area of OC according to gestational week millimeter square

研究概览

简要总结

Evaluation of prenatal optic chiasm (OC) is important for the differential diagnosis of septo-optic dysplasia (SOD), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (CSP). Septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, CSP agenesis, and developmental delay.

详细描述

Up to now, optic chiasm measurement were all done in the third trimester. in the present study, OC will be measure directly in a 2D ultrasound in coronal plane within the second trimester. In fetuses with SP agenesis, the morphology and width of the OC visual pathway may be a suitable tool to assess its development. It can also assist in the difficult task of providing prenatal counseling when faced with a diagnosis of CP agenesis. therefore In the present study, it was planned to show the optic chiasm in the screening of septooptic dysplasia by ultrasound between 16-20 weeks of gestation, and to measure the optic chiasma width and length, and to determine the mean values in the second trimester.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • aged greater than 18 years old
  • having singleton pregnancy

排除标准

  • being under the age of 18
  • having IVF pregnancy
  • having multiple pregnancy
  • comorbidity during pregnancy
  • smoking history
  • presence of familial genetic disease

结局指标

主要结局

Calculation of average area of OC according to gestational week millimeter square

时间窗: 2 months

Calculation of average width of OC according to gestational week in millimeter

时间窗: 2 months

Calculation of average height of OC according to gestational week in millimeter

时间窗: 2 months

次要结局

未报告次要终点

研究者

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

Süleyman Salman

Associate Professor

Gaziosmanpasa Research and Education Hospital

研究点 (1)

Loading locations...

相似试验