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临床试验/NCT01081379
NCT01081379Unknown不适用

The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Maternal-Fetal transmission of CMV

研究概览

简要总结

The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

详细描述

Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful.

Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus.

Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study.

Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies.

排除标准

  • Underlying immune deficiencies
  • Other pregnancy complications

结局指标

主要结局

Maternal-Fetal transmission of CMV

时间窗: 1 year

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

Yedidia Yifat

Yechiel Schlesinger, MD, Shaare Zedek Medical Center.

Shaare Zedek Medical Center

研究点 (1)

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