Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— GYNESEP  

Official title:

Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248438
• Other study ID #: CHUBX 2021/49
• Status: Completed
• Start date: May 11, 2022
• Est. completion date: May 9, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Questionnaire
Questionnaire

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de neurologie	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gynecological scores of women from 18 to 40 years old with multiple sclerosis with a standardized questionnaire created for the study.	17 questions concerning contraception, number of gynecological follow up, frequency of cervical cancer screening, desire of pregnancy.	At baseline (Day 0)
Secondary	Proportion of patients affected by SEP with an Impact on sexuality according to Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19).	that varies between 19 and 95 with higher values mean higher levels of Impact on sexuality	At baseline (Day 0)
Secondary	Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).	that varies between 9 and 63 with higher values mean higher levels of Impact on life quality	At baseline (Day 0)
Secondary	Proportion of patients affected by SEP with an impact on life quality according to EHD scores ("échelle d'humeur dépressive" in french)	that varies between 11 and 44 with higher values mean higher levels of Impact on life quality	At baseline (Day 0)
Secondary	Proportion of patients affected by SEP with an impact on life quality according to Multiple Sclerosis Quality of life (MusiQol) scores	that varies between 31 and 155 with higher values mean higher levels of Impact on life quality	At baseline (Day 0)