A Next Generation point-of Care Urine Test (CercaTestTM Red) for Prediction of Preeclampsia in Women With Suspected Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to predict preeclampsia in pregnant women aged 18 years or older with a singleton pregnancy at 20 or more weeks of gestation who present with suspected signs or symptoms of preeclampsia. The main questions it aims to answer is:
- Can a next-generation point-of-care urine test (CercaTest™ Red) accurately predict preeclampsia in women with suspected preeclampsia? Participants will be informed and asked to sign a written consent to participate in the study. Complete standard clinical assessments for suspected preeclampsia, including evaluations for new-onset hypertension, proteinuria, maternal end-organ dysfunction, or uteroplacental dysfunction. A urine sample is required to be evaluated using the CercaTest™ Red point-of-care diagnostic test.
详细描述
This is a prospective, multicentre, double-blinded, non-interventional cohort study conducted in tertiary obstetrics units. The study aims to evaluate the predictive performance of a next-generation point-of-care urine test, CercaTest™ Red, for ruling out the development of preeclampsia (PE) within one week of testing in Asian women with suspected PE. Additionally, the study will assess the test's predictive performance for adverse maternal and neonatal outcomes and will develop a short-term prediction model combining CercaTest™ Red results with other clinical parameters.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at 18 years old or above
- •Singleton pregnancy
- •Gestational age: ≥20 weeks of gestation
- •Presenting with suspected PE signs or symptoms:
- •New onset of hypertension. New onset of proteinuria Maternal end-organ dysfunction,
- •Uteroplacental dysfunction:
- •- Informed and written consent
排除标准
- •Confirmed diagnosis of PE
- •Confirmed diagnosis of HELLP syndrome
- •Confirmed diagnosis of a fetal chromosomal or structural abnormality
- •Visible haematuria
- •Multiple pregnancies
- •Patients with pre-existing renal disease
- •Concomitant participation in another clinical trial
- •Investigational medicinal product received in the past 3 months (90 days)
- •Unwilling to give informed consent.
研究者
Chiu Yee Liona Poon
Professor, Department of Obstetrics and Gynaecology
Chinese University of Hong Kong