CercaTest™ Red Urine Test for Predicting Preeclampsia (PRE-CERCA)
2. juni 2026 opdateret af: Chiu Yee Liona Poon, Chinese University of Hong Kong
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Hong Kong, 0000
- The Chinese University of Hong Kong
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Performance for the Prediction of Preeclampsia (PE)
Tidsramme: Within 7 days after the index CercaTest™ Red urine test
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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.
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Within 7 days after the index CercaTest™ Red urine test
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Liona Chiu Yee Poon, Professor (Clinic), Chinese University of Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. januar 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
20. maj 2026
Først indsendt, der opfyldte QC-kriterier
2. juni 2026
Først opslået (Faktiske)
4. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- PE
- Præeklampsi
- svangerskabsforhøjet blodtryk
- graviditetsinduceret hypertension
- Hurtig diagnostisk test
- hypertensive lidelser i graviditeten
- urinprøve
- Biomarker -forudsigelse
- suspected preeclampsia
- point-of-care test (POCT)
- in vitro diagnostic (IVD)
- CercaTest Red
- CercaTest
- Shuwen Biotech
- Urine test for preeclampsia
- Point-of-care preeclampsia screening
- Preeclampsia prediction kit
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025.135
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