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临床试验/NCT01916928
NCT01916928已完成不适用

The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage

Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.

研究概览

简要总结

Women presenting to Washington Hospital Center with fetal loss would be offered participation in the study. The objective is to determine if ccffDNA obtained from maternal blood is present in the setting of missed abortion or fetal demise.

The investigators primary hypothesis is that cell free fetal DNA will be present in maternal blood in the presence of a failed pregnancy.

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

入选标准

  • Women diagnosed with Intrauterine fetal demised or missed abortion

排除标准

  • Patients diagnosed with threatened abortion with cardiac activity present
  • Patients with IUFD who have delivered the fetus (the induction process may already be in process, however, the fetus and placenta must be in situ at the time of blood sampling)
  • Patients with known genetic abnormalities or mental retardation as a result of chromosomal abnormalities 13, 18, 21, or sex chromosomes.
  • Children under the age of 18
  • Patients not fluent in or unable to consent to the study in English

结局指标

主要结局

The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.

时间窗: During initial presentation for treatment

Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise

次要结局

  • The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.(3-4 weeks after specimen processing)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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