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CercaTest™ Red Urine Test for Predicting Preeclampsia (PRE-CERCA)

2026年6月2日更新者：Chiu Yee Liona Poon、Chinese University of Hong Kong

A Next Generation point-of Care Urine Test (CercaTestTM Red) for Prediction of Preeclampsia in Women With Suspected Preeclampsia

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.

研究概览

地位

主动，不招人

条件

先兆子痫

详细说明

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.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

香港
- - Hong Kong、香港、0000
    - The Chinese University of Hong Kong

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population consists of pregnant women aged 18 years or above, with a singleton gestation of 20 weeks or greater, who present to the clinical setting with signs or symptoms suggestive of new-onset preeclampsia (including hypertension, proteinuria, maternal end-organ dysfunction, or uteroplacental dysfunction). Participants are drawn from individuals receiving obstetric care who have not yet established diagnosis of preeclampsia or HELLP syndrome, and who do not have pre-existing renal disease or known fetal chromosomal or structural abnormality.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Diagnostic Performance for the Prediction of Preeclampsia (PE) 大体时间：Within 7 days after the index CercaTest™ Red urine test	The CercaTest™ Red urine point-of-care test is used for the prediction of preeclampsia (PE) within one week of testing in women with suspected PE. Diagnostic performance (negative predictive value or positive predictive value) will be assessed by comparing CercaTest™ Red results to the clinical diagnosis of PE established within 7 days post-index test. Clinical diagnosis of PE follows standard professional guidelines (e.g., ACOG or ISSHP), requiring new-onset hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg) with either new-onset proteinuria or maternal end-organ dysfunction.	Within 7 days after the index CercaTest™ Red urine test

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chinese University of Hong Kong

调查人员

首席研究员：Liona Chiu Yee Poon, Professor (Clinic)、Chinese University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月31日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)