CercaTest™ Red Urine Test for Predicting Preeclampsia (NCT07625501) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CercaTest™ Red Urine Test for Predicting Preeclampsia
Hong Kong1,000 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Performance for the Prediction of Preeclampsia (PE)
Timeframe: Within 7 days after the index CercaTest™ Red urine test