Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05961267
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARIGYN
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: