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NCT Number: NCT05961267

Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40.

Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common.

Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans.

In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear.

In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues.

Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

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Key information

Conditions

Arthritis, Rheumatoid Ankylosis Arthritis Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mixed Connective Tissue Disease Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Scleroderma, Systemic Sjogren's Syndrome Skin Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

About this study

To evaluate the gynecological follow-up of patients with autoimmune diseases or inflammatory rheumatism by:

  • Assessing the proportion of patients reporting having contraception described as effective by guidelines within one year in the study population.
  • Evaluating the proportion of patients reporting having had a consultation for screening or follow-up for cervical dysplasia in the year.

Descriptive analysis of :

  • Factors associated with effective contraceptive use and frequency of cervical smear screening.
  • The impact of the disease on the pregnancy project.
  • The appropriateness of the chosen contraceptive and the patients' comorbidities.
  • The prevalence of Human Papillomavirus (HPV) infections, cervical dysplasia, cervical cancer in this French population at risk.
  • Barriers to gynecological care.

Who can participate

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

Inclusion criteria

  • Female patient over 18 years of age
  • Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)
  • Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
  • French-speaking patient with no comprehension problems
  • Person affiliated with or benefiting from a social securitý scheme
  • Patient who received information about the protocol and gavé her consent

Exclusion criteria

  • Pregnant or breastfeeding patient
  • Patient with a history of total hysterectomy
  • Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).

Treatment and study plan

Questionnaire

Behavioral

A gynecological follow-up questionnaire will be proposed to patients with one of the above mentioned pathologies. This is a standardized questionnaire specifically designed for this study.

Primary outcomes

  1. Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.

    Time frame: At baseline (Day 0)

Secondary outcomes

  1. Proportion of patients who report using effective contraception during the year.

    Time frame: At baseline (Day 0)

  2. Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.

    Time frame: At baseline (Day 0)

  3. Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.

    Time frame: At baseline (Day 0)

  4. Prevalence of HPV infections in the study sample.

    Time frame: At baseline (Day 0)

  5. Prevalence of cervical dysplasia in the study sample.

    Time frame: At baseline (Day 0)

  6. Prevalence of cervical cancer in the study sample.

    Time frame: At baseline (Day 0)

  7. Proportion of patients who report not having consulted their gynecologist during the year.

    Time frame: At baseline (Day 0)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MARIGYN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Jun 5, 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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