← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07625501). StuddyBuddy aggregates publicly available trial information.