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临床试验/NCT00970047
NCT00970047已完成不适用

Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation

Sequenom, Inc.3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
3

研究概览

简要总结

Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

详细描述

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Subject is 18-64 years of age
  • Subject is female
  • Subject is pregnant and between 6 and 16 weeks of gestation
  • Subject provides a signed and dated informed consent
  • If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
  • If subject undergoes an invasive procedure, she agrees to provide the fetal sex results

排除标准

  • 未提供

研究者

申办方类型
Industry

研究点 (3)

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