Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

NCT ID: NCT05248438

Last Updated: 2023-06-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-05-09

Brief Summary

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The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).

Detailed Description

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Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects (120 000 subjects in France). The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 man.

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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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple sclerosis patients

patients affected by multiple sclerosis based on McDonald Criteria 2017

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire

Interventions

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Questionnaire

Questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 to 40 years old ;
* 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

* pregnant or breastfeeding women ;
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 38277979 (View on PubMed)

Other Identifiers

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CHUBX 2021/49

Identifier Type: -

Identifier Source: org_study_id

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