NCT07625501Active, not recruiting
CercaTest™ Red Urine Test for Predicting Preeclampsia
A Next Generation point-of Care Urine Test (CercaTestTM Red) for Prediction of Preeclampsia in Women With Suspected Preeclampsia
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 20 May 2026
- Start date
- 31 Jan 2026
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- High blood pressure
- NCT number
- NCT07625501
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 31 Jan 2026 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant participation in another clinical trial
- Investigational medicinal product received in the past 3 months (90 days)
Other illness
- Confirmed diagnosis of HELLP syndrome
- Patients with pre-existing renal disease
Other
- Confirmed diagnosis of PE
- Confirmed diagnosis of a fetal chromosomal or structural abnormality
- Visible haematuria
- Multiple pregnancies
- Unwilling to give informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.