NCT05961267Completed
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 318 (actual)
- First submitted
- 17 Jul 2023
- Start date
- 24 Jul 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Sjögren's disease, Systemic sclerosis (scleroderma), Ankylosing spondylitis, Rheumatoid arthritis
- NCT number
- NCT05961267
What you commit to
- Study type: Observational
- Participants enrolled: 318
- From 24 Jul 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with a history of total hysterectomy
Other
- Pregnant or breastfeeding patient
- 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).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux - service de rhumatologie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
Related publications
- Cervical cancer screening practices among patients with autoimmune and inflammatory rheumatic diseases: a descriptive cross-sectional observational study.BMC Womens Health · 2026 · PMID 42035038
- Prevalence of effective contraceptive use among patients with rheumatic diseases: a descriptive study.BMC Rheumatol · 2026 · PMID 41680954
This page is information, not medical advice. Discuss any trial with your doctor.