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Simple urine test could spot dangerous pregnancy condition early

NCT ID NCT07625501

Diagnosis Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new urine test called CercaTest™ Red to predict preeclampsia in pregnant women who show signs of the condition. Preeclampsia is a serious complication involving high blood pressure and organ damage. The test is designed to be used at the point of care, giving quick results. Researchers will compare the test's predictions to actual diagnoses within one week to see how accurate it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this test could help doctors quickly rule out or predict preeclampsia in pregnant women, leading to earlier care and fewer complications.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace current methods, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertension, pregnancy-induced preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia

Contacts and locations

Locations

  • The Chinese University of Hong Kong

    Hong Kong, 0000, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.