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

Arthritis, Rheumatoid Clinical Trial

— MARIGYN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961267
• Other study ID #: CHUBX 2023/25
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Bordeaux
• Contact: Christophe RICHEZ, Prof
• Phone: (0)556795556
• Email: christophe.richez[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 security´ scheme

• Patient who received information about the protocol and gave´ 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).

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Autoimmune Diseases
• Connective Tissue Diseases
• Lupus Erythematosus, Systemic
• Mixed Connective Tissue Disease
• Rheumatic Diseases
• Rheumatic Fever
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sjogren's Syndrome
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de rhumatologie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.		At baseline (Day 0)
Secondary	Proportion of patients who report using effective contraception during the year.		At baseline (Day 0)
Secondary	Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.		At baseline (Day 0)
Secondary	Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.		At baseline (Day 0)
Secondary	Prevalence of HPV infections in the study sample.		At baseline (Day 0)
Secondary	Prevalence of cervical dysplasia in the study sample.		At baseline (Day 0)
Secondary	Prevalence of cervical cancer in the study sample.		At baseline (Day 0)
Secondary	Proportion of patients who report not having consulted their gynecologist during the year.		At baseline (Day 0)