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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Antiphospholipid Syndrome

Treatments

Procedure: Diffusion tensor imaging MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03600636
LOCAL/2018/JCG-01

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Control
Other group
Treatment:
Procedure: Diffusion tensor imaging MRI
antiphospholipid syndrome patients
Other group
Treatment:
Procedure: Diffusion tensor imaging MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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