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临床试验/NCT01649128
NCT01649128已完成不适用

Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations

CHA University0 个研究点目标入组 262 人开始时间: 2009年8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
262
主要终点
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio

研究概览

简要总结

For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.

详细描述

A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).

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
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea

排除标准

  • early onset and cases not to measure the sFlt/PlGF ratio and other markers
  • twin pregnancy
  • Chronic hypertension
  • prior history of preeclampsia
  • pregestational diabetes mellitus
  • gestational diabetes mellitus
  • patients delivered before 35 weeks of gestation
  • preeclamptic patients with onset before 35 weeks of gestation
  • patients with body mass index 25kg/m2 or greater
  • maternal age 40 years older

结局指标

主要结局

identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio

时间窗: at delivery

次要结局

  • identification of patients at risk for late-onset preeclampsia with combined biochemical markers(at delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Hyun Cha

professor

CHA University

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