PreeclampsiaPRE-CERCANCT07625501
CercaTest™ Red Urine Test for Predicting Preeclampsia
An observational study of Preeclampsia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Concomitant participation in another clinical trial
- Investigational medicinal product received in the past 3 months (90 days)
- Unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Next Generation point-of Care Urine Test (CercaTestTM Red) for Prediction of Preeclampsia in Women With Suspected Preeclampsia
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.
Read the detailed description
This is a prospective, multicentre, double-blinded, non-interventional cohort study conducted in tertiary obstetrics units. The study aims to evaluate the predictive performance of a next-generation point-of-care urine test, CercaTest™ Red, for ruling out the development of preeclampsia (PE) within one week of testing in Asian women with suspected PE. Additionally, the study will assess the test's predictive performance for adverse maternal and neonatal outcomes and will develop a short-term prediction model combining CercaTest™ Red results with other clinical parameters.
- 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
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after the index CercaTest™ Red urine test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start31 Jan 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiu Yee Liona Poon, Chinese University of Hong Kong
- Investigators
- Liona Chiu Yee Poon, Professor (Clinic), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625501
- Sponsor's protocol ID
- 2025.135
- Acronym
- PRE-CERCA
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Next Generation point-of Care Urine Test (CercaTestTM Red) for Prediction of Preeclampsia in Women With Suspected Preeclampsia
- ClinicalTrials.gov ID
- NCT07625501
- Acronym / sponsor ID
- PRE-CERCA / 2025.135
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, PE, suspected preeclampsia, gestational hypertension, pregnancy-induced hypertension, hypertensive disorders of pregnancy, urine test, point-of-care test (POCT)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicentre, double-blinded, non-interventional cohort study conducted in tertiary obstetrics units. The study aims to evaluate the predictive performance of a next-generation point-of-care urine test, CercaTest™ Red, for ruling out the development of preeclampsia (PE) within one week of testing in Asian women with suspected PE. Additionally, the study will assess the test's predictive performance for adverse maternal and neonatal outcomes and will develop a short-term prediction model combining CercaTest™ Red results with other clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (9 listed)
- Confirmed diagnosis of PE
- Confirmed diagnosis of HELLP syndrome
- Confirmed diagnosis of a fetal chromosomal or structural abnormality
- Visible haematuria
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance for the Prediction of Preeclampsia (PE)
Time frame: Within 7 days after the index CercaTest™ Red urine test
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liona Chiu Yee Poon, Professor (Clinic) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance for the Prediction of Preeclampsia (PE) (time frame: Within 7 days after the index CercaTest™ Red urine test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.