CercaTest™ Red Urine Test for Predicting Preeclampsia

N/AActive Not RecruitingNCT07625501

Chinese University of Hong Kong1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Preeclampsia

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Diagnostic Performance for the Prediction of Preeclampsia (PE)

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.

Time frame: Within 7 days after the index CercaTest™ Red urine test