Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

NCT05248438 | Completed

• 1 other identifier: CHUBX 2021/49
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; gynecological care; sexuality; contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of patients affected by SEP with an Impact on sexuality according to Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19).

  At baseline (Day 0)

• Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).

  At baseline (Day 0)

• Proportion of patients affected by SEP with an impact on life quality according to EHD scores ("échelle d'humeur dépressive" in french)

  At baseline (Day 0)

• Proportion of patients affected by SEP with an impact on life quality according to Multiple Sclerosis Quality of life (MusiQol) scores

  At baseline (Day 0)

Study Arms (1)

Multiple sclerosis patients

patients affected by multiple sclerosis based on McDonald Criteria 2017

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire

Multiple sclerosis patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient Aged between 18 to 40 years old, affected by multiple sclerosis based on McDonald Criteria 2017

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

CHU de Bordeaux - service de neurologie

Bordeaux, France

Location

Related Publications (1)

• 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.

  PMID: 38277979 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Sexuality

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Valérie BERNARD, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 21, 2022
• Study Start: May 11, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

FR (1)