Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
NCT ID: NCT05248438
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
192 participants
OBSERVATIONAL
2022-05-11
2023-05-09
Brief Summary
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Detailed Description
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Many different treatments exist, depending on the severity of the pathology and the evolutivity of the disease. It is very important to understand that some treatments are not compatible with pregnancy. In these circumstances, a regular gynecological follow-up seems to be essential, to discuss contraception and pregnancy. Besides, some treatments have an immunosuppressive activity that is why a gynecological aftercare is necessary, especially in the detection of papillomavirus for cervical cancer.
The neurologist can advise about gynecological issues, but he cannot take care of the gynecological follow-up, that is why it is very interesting to study the quality of the gynecological follow-up. The investigators aim to study gynecological care of patients with multiple sclerosis using a questionnaire made especially for this project. The questionnaire will be filled by patients when they come in the neurology department for a consultation or during their visit at day hospital. At the same time, they will fill a standardized questionnaire about sexuality and quality of life.
This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center (CRCSEP).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Multiple sclerosis patients
patients affected by multiple sclerosis based on McDonald Criteria 2017
Questionnaire
Questionnaire
Interventions
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Questionnaire
Questionnaire
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of multiple sclerosis based on McDonald Criteria 2017 ;
* Patient whose clinical data are referenced in the European Database for Multiple Sclerosis (EDMUS) clinical database (OFSEP database for collecting clinical data from patients followed in the neurology department) ;
* French-speaking, without comprehension disorders ;
* being affiliated to health insurance ;
* Willing to participate and to sign informed consent.
Exclusion Criteria
* patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
18 Years
40 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Valérie BERNARD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU de Bordeaux - service de neurologie
Bordeaux, , France
Countries
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References
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Renaud J, Buissonniere P, Dulau C, Deloire M, Hontarrede F, Montcuquet A, Chansel-Debordeaux L, Hocke C, Ouallet JC, Ruet A, Bernard V. Gynaecological follow-up for women of reproductive age with multiple sclerosis: The GYNESEP study. Mult Scler Relat Disord. 2024 Mar;83:105448. doi: 10.1016/j.msard.2024.105448. Epub 2024 Jan 14.
Other Identifiers
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CHUBX 2021/49
Identifier Type: -
Identifier Source: org_study_id
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