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Brain scans reveal hidden damage years after pregnancy complication

NCT ID NCT03600636

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study uses special MRI scans to see if the white matter in the brain gets worse over time in women who have obstetric antiphospholipid syndrome, a condition that can cause pregnancy loss. Researchers will compare brain images from 40 women who were part of an earlier study. The goal is to understand if this condition leads to long-term brain changes, which could help guide future care.

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 this study finds that white matter deteriorates, it could point toward the need for brain monitoring or early treatment in these patients.
What could go wrong
This is a small, observational study with no treatment being tested. It only looks at brain changes, so it cannot prove any therapy works or is safe.

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

40 people

The number who actually took part.

Started

Dec 2018

Finished

Feb 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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is at least 18 years old * For the target population: only women included in the publication by Pereira et al (2016) will be included, with no obsteric history (fetal death \>10 weeks or 3 unexplained consecutive losses \<10 weeks) * For the test group: Patients must be positive for antiphospholipid antibodies based on results from Pereira et al (2016) * For the control group. Patients must be negative for antiphospholipid antibodies according to results from Pereira et al (2016) Exclusion Criteria: * The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant, parturient or breast feeding * The patient is claustrophobic * The patient has a metallic foreign body (e.g. pacemaker) * The patient has experienced pregnancy loss linked to infectious, metabolic, anatomic or hormonal factors

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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 syndrome

Contacts and locations

Locations

  • CHU Nimes

    Nîmes, 30029, France

More trials for these conditions

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