Far Eastern Memorial Hospital
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
- 否
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
Sheng-Mou Hsiao
Head of Department of Obstetrics & Gynecology, Associate Professor
Far Eastern Memorial Hospital
