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临床试验/NCT04935138
NCT04935138终止不适用

Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Quest Diagnostics-Nichols Insitute1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
78
试验地点
1
主要终点
microarray analysis of products of conception (POC)

研究概览

简要总结

The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

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 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •5-20 weeks of gestation by ultrasound
  • •Miscarriage diagnosed by ultrasound
  • •Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

排除标准

  • •Maternal age < 18 years
  • •No visible pregnancy tissue on ultrasound
  • •Multiple fetal gestation (> than singleton)
  • •Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
  • •No microarray testing is planned on the product of conception
  • •Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
  • •Patient unable to provide consent

结局指标

主要结局

microarray analysis of products of conception (POC)

时间窗: 7 days

chromosome anomalies

次要结局

未报告次要终点

研究者

发起方
Quest Diagnostics-Nichols Insitute
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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