Clinical trial NCT05248438: Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
Official title: Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
gynecological care
sexuality
contraception
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-02-21
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Aged between 18 to 40 years old, affected by multiple sclerosis based on McDonald Criteria 2017

Brief summary: 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: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Gynecological scores of women from 18 to 40 years old with multiple sclerosis with a standardized questionnaire created for the study.
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: Proportion of patients affected by SEP with an Impact on sexuality according to Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19).
timeFrame: At baseline (Day 0)
measure: Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).
timeFrame: At baseline (Day 0)
measure: Proportion of patients affected by SEP with an impact on life quality according to EHD scores ("échelle d'humeur dépressive" in french)
timeFrame: At baseline (Day 0)
measure: Proportion of patients affected by SEP with an impact on life quality according to Multiple Sclerosis Quality of life (MusiQol) scores
timeFrame: At baseline (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de neurologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Valérie BERNARD, MD
role: PRINCIPAL_INVESTIGATOR
References: