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临床试验/NCT02521337
NCT02521337Unknown不适用

PreTerm RNA in Maternal Serum

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Number of women with preterm labor that present a unique RNA cluster

研究概览

简要总结

Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. The incidence of preterm birth in Israel in the last years is around 7-8%.

Despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality.

In the last decade, small RNAs have emerged as an important player in both physiological and pathophysiological responses. These single strands, non-coding regulatory RNA molecules are responsible for post transcriptional regulation of target genes. Hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth.

The main objective of this study is to identify a distinctive expression profile of maternal circulating RNAs that will be used as biomarkers for preterm birth.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor.
  • Women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor.
  • Women with singleton pregnancy in term active labor (weeks 37-40).

排除标准

  • Exclusion criteria will include:
  • multiple gestation,
  • major fetal anomalies,
  • severe preeclampsia,
  • chronic steroid or immunosuppressive drug use,
  • active immunological illness,
  • and/or pregestational and gestational DM.

结局指标

主要结局

Number of women with preterm labor that present a unique RNA cluster

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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