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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT05961267

Collaborator

(none)

800

Enrollment

Location

11.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid Spondylitis, Ankylosing Lupus Erythematosus, Systemic Scleroderma, Systemic Sjogren's Syndrome Mixed Connective Tissue Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 24, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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).