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Protein test may spot preeclampsia risk in High-Risk pregnancies

NCT ID NCT04319341

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examined whether measuring a protein called ADAMTS13 in early pregnancy can help predict preeclampsia in women with antiphospholipid antibody syndrome (APS). Researchers analyzed stored blood samples from 513 women in the NOH-APS cohort who became pregnant after their APS diagnosis. The goal was to see if ADAMTS13 activity, antigen levels, or autoantibodies were linked to later development of preeclampsia or related complications.

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 blood test that helps predict preeclampsia risk early in pregnancy for women with antiphospholipid antibody syndrome.
What could go wrong
This is an observational study using stored samples, not a treatment trial. It may not prove that ADAMTS13 directly causes or prevents preeclampsia.

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

513 people

The number who actually took part.

Started

Apr 2020

Finished

Dec 2020

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

Patients with an initially pure, non-thrombotic oAPS; included in the NOH-APS cohort; having been followed in Nîmes for their first pregnancy following the diagnosis of oAPS; N=513.

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: * Presence of frozen plasma samples from the positive pregnancy test blood sample. * Adult patients, included in the NOH-APS cohort, who have successfully initiated a new pregnancy after diagnosis of oAPS. Exclusion Criteria: * Absence of frozen plasma sample from the blood sample from the positive pregnancy test. * Patient who objected to the use of their data.

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome

As listed by the trial registrant

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

Antiphospholipid antibody syndrome in pregnancy

Contacts and locations

Locations

  • CHU de Nîmes - Hôpital Universitaire Carémea

    Nîmes, 30029, France