ClinicalTrials.gg
Status unknownNCT06117228Gyn-T21Updated Nov 7, 2023

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

An observational study in Down Syndrome, sponsored by Université de Reims Champagne-Ardenne. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Université de Reims Champagne-Ardenne · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Down Syndrome

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Keywords

  • Gynaecological follow-up
  • down syndrome
  • women
03

In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's planned enrollment of 100 is below the median of 141 across 145 observational studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Université de Reims Champagne-Ardenne is the lead sponsor of 64 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • women with a disability other than Down's syndrome
  • Not agreeing to take part in the study
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherData collection

    Data collection

06

What researchers measure

Primary outcomes

  1. Gynaecological follow-up

    Presence or not of gynaecological follow-up

    Time frame: Day 0

07

Study locations

1 site
  • Ufr Medecine Urca
    Reims, 51100, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06117228
Lead sponsor
Université de Reims Champagne-Ardenne
Responsible party
Sponsor
First posted
Nov 3, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Feb 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Barbe Coralie, DR
Contact
coralie.barbe@univ-reims.fr
0326913865 ext. +33
CURRS CURRS
Contact
curss@univ-reims.fr
0326918822 ext. +33
Muller Gaëlle
principal investigator · Université de Reims Champagne-Ardenne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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