跳至主要内容
临床试验/NCT04021680
NCT04021680招募中不适用

Far Eastern Memorial Hospital

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
The sensitivity and specificity of this screening program to detect preeclampsia

研究概览

简要总结

To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

详细描述

The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.

In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

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

入选标准

  • Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.

排除标准

  • Women who are not regularly inspected or not receiving prenatal care in this institution.
  • Women who received first trimester pre-eclampsia screening test at other institution

结局指标

主要结局

The sensitivity and specificity of this screening program to detect preeclampsia

时间窗: 5 years

次要结局

未报告次要终点

研究者

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

Sheng-Mou Hsiao

Head of Department of Obstetrics & Gynecology, Associate Professor

Far Eastern Memorial Hospital

研究点 (1)

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