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Active Not Recruiting NCT07625501

CercaTest™ Red Urine Test for Predicting Preeclampsia

Conditions: Preeclampsia

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Chinese University of Hong Kong

Location: The Chinese University of Hong Kong Hong Kong

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07625501). StuddyBuddy aggregates publicly available trial information.