Clinical trial NCT05961267: Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Official title: Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Sjogren's Syndrome
Mixed Connective Tissue Disease
Keywords: Auto-immune diseases
rare auto-immune diseases
contraception
gynecological follow-up
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: Proportion of patients who report using effective contraception during the year.
timeFrame: At baseline (Day 0)
measure: Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.
timeFrame: At baseline (Day 0)
measure: Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.
timeFrame: At baseline (Day 0)
measure: Prevalence of HPV infections in the study sample.
timeFrame: At baseline (Day 0)
measure: Prevalence of cervical dysplasia in the study sample.
timeFrame: At baseline (Day 0)
measure: Prevalence of cervical cancer in the study sample.
timeFrame: At baseline (Day 0)
measure: Proportion of patients who report not having consulted their gynecologist during the year.
timeFrame: At baseline (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de rhumatologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Christophe RICHEZ, Prof
role: PRINCIPAL_INVESTIGATOR
References: