Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2020-02-29

Brief Summary

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The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time

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Detailed Description

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Conditions

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Antiphospholipid Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Group Type OTHER

Diffusion tensor imaging MRI

Intervention Type PROCEDURE

1. axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2.
2. Fluid-attenuated inversion recovery
3. three-dimensional axial image weighted in T1
4. axial echo-planar image sequence
5. three-dimensional pulse sequence axial flight time

antiphospholipid syndrome patients

Group Type OTHER

Diffusion tensor imaging MRI

Intervention Type PROCEDURE

1. axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2.
2. Fluid-attenuated inversion recovery
3. three-dimensional axial image weighted in T1
4. axial echo-planar image sequence
5. three-dimensional pulse sequence axial flight time

Interventions

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Diffusion tensor imaging MRI

1. axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2.
2. Fluid-attenuated inversion recovery
3. three-dimensional axial image weighted in T1
4. axial echo-planar image sequence
5. three-dimensional pulse sequence axial flight time

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes