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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 (CercaTestâ„¢ 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 CercaTestâ„¢ Red point-of-care diagnostic test.
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, CercaTestâ„¢ 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 CercaTestâ„¢ Red results with other clinical parameters.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days after the index CercaTest™ Red urine test |
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Inclusion Criteria:
New onset of hypertension. New onset of proteinuria Maternal end-organ dysfunction,
Uteroplacental dysfunction:
- Informed and written consent
Exclusion Criteria:
This study evaluates clinical signs and potential complications specifically unique to pregnant women.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Liona Chiu Yee Poon, Professor (Clinic) | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | 0000 | Hong Kong |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |