CercaTest™ Red Urine Test for Predicting Preeclampsia

NCT07625501 | Active Not Recruiting

• 1 other identifier: 2025.135
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Preeclampsia; PE; suspected preeclampsia; gestational hypertension; pregnancy-induced hypertension; hypertensive disorders of pregnancy; urine test; point-of-care test (POCT); Rapid diagnostic test; in vitro diagnostic (IVD); Biomarker prediction; CercaTest Red; CercaTest; Shuwen Biotech; Urine test for preeclampsia; Point-of-care preeclampsia screening; Preeclampsia prediction kit

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 7 days after the index CercaTest™ Red urine test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study evaluates clinical signs and potential complications specifically unique to pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liona Chiu Yee Poon, Professor (Clinic)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 4, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

HK (1)