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临床试验/NCT03903393
NCT03903393Unknown不适用

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2019年3月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
260
试验地点
1
主要终点
The RNA expression levels of lncRNAs

研究概览

简要总结

To identify lncRNAs differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with normal pregnancy .

详细描述

Preeclampsia (PE) is a pregnancy syndrome characterized by hypertension and proteinuria, and a leading cause of maternal and fetal morbidity and mortality, with poorly defined pathophysiological mechanisms remain. Circulating lncRNAs are long, noncoding RNA molecules, which negatively regulate gene expression, and considered as promising biomarkers for PE. The objective of the study is to evaluate circulating lncRNA signatures in women with PE compared to healthy women, and in women sub-grouped per PE severity. This study assessed lncRNA expression profile in the serum at early stages of gestation of women who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with uncomplicated pregnancies. Circulating lncRNA was extracted from maternal serum. This study also assess lncRNA expression profile in the placenta tissues of PE patients and healthy pregnant women.

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • new onset hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg on two occasions at least 4 h apart) after 20 weeks of gestation in women who previously had normal blood pressure.
  • proteinuria (the excretion of 300 mg or more of protein in a 24-hour urine collection)or other signs/symptoms of preeclampsia after 20 weeks of gestation in women who previously had normal blood pressure.

排除标准

  • maternal infections
  • chemical dependency
  • known major foetal or chromosomal anomalies
  • intrahepatic cholestasis during pregnancy
  • assisted reproductive technology (ART) treatments
  • chronic hypertension.

结局指标

主要结局

The RNA expression levels of lncRNAs

时间窗: 5 months

the serum of patients with preeclampsia and in the serum of normal controls were measured by qRT-PCR.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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