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NCT06117228 Clinical Trial

Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Down Syndrome Clinical Trial

— Gyn-T21  

Official title:
Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06117228
Other study ID # 2023_RIPH_016_Gyn-T21
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date May 1, 2024

Study information
Verified date October 2023
Source Université de Reims Champagne-Ardenne
Contact Barbe Coralie, DR
Phone 0326913865
Email coralie.barbe@univ-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Gynaecological check-ups for women are recommended in France. However, some groups of the population are affected by a lack or absence of medical surveillance. In France, there are one million people with an intellectual disability, including 50,000 with Down syndrome. Although this disability causes numerous physical and psychological deficits, no gynaecological consequences have yet been demonstrated. Regular gynaecological check-ups are therefore necessary, according to French recommendations. However, several studies have shown that women with mental illness receive less or no gynaecological care.

Description:

The aim is to describe the gynaecological follow-up of women with Down syndrom in France.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - women with Down's syndrome, - aged between 18 and 30, - whether or not they are being followed up in a medical facility, - who agree to take part in the study. Exclusion Criteria: - women with a disability other than Down's syndrome - Not agreeing to take part in the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Data collection
Data collection

Locations
Country Name City State
France Ufr Medecine Urca Reims

Sponsors (1)
Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gynaecological follow-up Presence or not of gynaecological follow-up Day 0
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