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

November 3, 2023 updated by: Université de Reims Champagne-Ardenne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Reims, France, 51100
        • Ufr Medecine Urca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

women with Down syndrome, aged 18 to 30, whether or not they are being followed up in medical facilities in France.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gynaecological follow-up
Time Frame: Day 0
Presence or not of gynaecological follow-up
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Reims Champagne-Ardenne

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_RIPH_016_Gyn-T21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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