Gyn-T21: Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Sponsor

Université de Reims Champagne-Ardenne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117228

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: Data collection

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
women with Down syndrome aged 18 to 30 women aged 18 to 30 with Down syndrome, whether or not they were receiving medical care, who agreed to take part in the study.	Other: Data collection Data collection

Arm

Intervention/Treatment

women with Down syndrome aged 18 to 30

women aged 18 to 30 with Down syndrome, whether or not they were receiving medical care, who agreed to take part in the study.

Other: Data collection

Data collection

Outcome Measures

Primary Outcome Measures

Gynaecological follow-up [Day 0]
Presence or not of gynaecological follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ufr Medecine Urca	Reims		France	51100

Sponsors and Collaborators

Université de Reims Champagne-Ardenne

Investigators

Principal Investigator: Muller Gaëlle, Université de Reims Champagne-Ardenne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université de Reims Champagne-Ardenne

ClinicalTrials.gov Identifier:

NCT06117228

Other Study ID Numbers:

2023_RIPH_016_Gyn-T21

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Université de Reims Champagne-Ardenne

Gynaecological follow-up

down syndrome

women

Additional relevant MeSH terms:

Down Syndrome

Study Results

No Results Posted as of Nov 7, 2023