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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Sjogren's Syndrome; Spondylitis, Ankylosing; Mixed Connective Tissue Disease
• Intervention / Treatment: Behavioral: Questionnaire

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux - service de rhumatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.	Behavioral: Questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.	At baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who report using effective contraception during the year.	At baseline (Day 0)
Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.	At baseline (Day 0)
Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.	At baseline (Day 0)
Prevalence of HPV infections in the study sample.	At baseline (Day 0)
Prevalence of cervical dysplasia in the study sample.	At baseline (Day 0)
Prevalence of cervical cancer in the study sample.	At baseline (Day 0)
Proportion of patients who report not having consulted their gynecologist during the year.	At baseline (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Christophe RICHEZ, Prof, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Delattre C, Uthuriague M, Barnetche T, Lambert M, Mehsen-Cetre N, Lazaro E, Truchetet ME, Hocke C, Richez C, Bernard V. Cervical cancer screening practices among patients with autoimmune and inflammatory rheumatic diseases: a descriptive cross-sectional observational study. BMC Womens Health. 2026 Apr 25. doi: 10.1186/s12905-026-04475-2. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: contraception; Auto-immune diseases; rare auto-immune diseases; gynecological follow-up
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Skin Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Spondylarthritis; Spondylitis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Spondylitis, Ankylosing; Sjogren's Syndrome; Scleroderma, Systemic; Arthritis, Rheumatoid; Mixed Connective Tissue Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: CHUBX 2023/25; 2023-A01207-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No