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Completed

NCT Number: NCT03600636

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

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

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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion tensor imaging MRI

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

Primary outcomes

  1. Mean diffusivity of white matter between groups

    Time frame: Day 0

    mm2/s

Secondary outcomes

  1. Fractional anisotropy of white matter between groups

    Time frame: Day 0

    Value between 0-1

  2. Radial diffusivity of white matter between groups

    Time frame: Day 0

    mm2/s

  3. Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

    Time frame: Day 0

    mm2/s

  4. Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

    Time frame: Day 0

    Value between 0-1

  5. Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

    Time frame: Day 0

    mm2/s

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: APS Follow Up

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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