CercaTest™ Red Urine Test for Predicting 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preeclampsia Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Chinese University of Hong Kong

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Diagnostic Performance for the Prediction of Preeclampsia (PE)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: PRE-CERCA

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 4, 2026
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting