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Urine clues may spot Pre-Eclampsia risk in hypertensive pregnancies

NCT ID NCT04520048

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study looks at whether tiny particles from blood vessels, found in urine, can help predict which pregnant women with high blood pressure will develop a dangerous condition called pre-eclampsia. Researchers will measure these particles in 110 pregnant women at two points during pregnancy. The goal is to find a simple, non-invasive way to identify those at highest risk.

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 could lead to a simple urine test to predict pre-eclampsia in pregnant women with high blood pressure, allowing earlier monitoring and care.
What could go wrong
This is an early exploratory study with only 110 participants, so results may not apply to all women. The test may not prove accurate enough for routine use.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

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

Started

Aug 2023

Expected to finish

Dec 2026

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.

Ages

18 to 40 years

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: * Patients with a hypertension disorder in pregnancy and/or preeclampsia from the 20th amenorrhea week until the 26th ± 2 amenorrhea week. * Age between 18 and 40 years old. * Having given written consent. * Patients affiliated to a social security scheme. Exclusion Criteria: * Presence of pathologies interfering in a major way with vascular parameters: known multicomplicated diabetes treated before pregnancy, hypercholesterolemia known (or LDL\>130 mg/dl), multicomplicated connectivitis, proven cardiovascular disease (ischemic heart disease, stroke, arteriopathy of the lower limbs, heart failure), pre-existing known renal failure (serum creatinine \>125 µmol/L) and/or pre-existing proteinuria ≥ 300 mg/24h). * Cardiac arrhythmia. * Hepatitis C, HIV infection (assay performed within 6 months prior to diagnosis of pre-eclampsia). * Recent history of venous (pulmonary embolism, phlebitis) or arterial (myocardial infarction, unstable angina, stroke, transient ischemic attack), thrombotic event ≤ 3 months. * Patient already engaged in a therapeutic protocol. * Patients under legal protective measures. * Patients receiving State Medical Assistance.

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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.

Gestational hypertension Hypertension disorders in pregnancy Pre-eclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Avicenne Hospital, Department of internal medicine

    RECRUITING

    Bobigny, Seine Saint Denis, 93000, France

  • AP-HP Jean Verdier Hospital, Gynecology and Obstetrics Department

    RECRUITING

    Bondy, Seine Saint Denis, 93140, France

  • AP-HP Laribosière Hospital, Gynecology and Obstetrics Department

    RECRUITING

    Paris, 75010, France

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