Down SyndromeGyn-T21NCT06117228
Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France
An observational study of Down Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with Down syndrome, aged 18 to 30, whether or not they are being followed up in medical facilities in France.
Who may be able to join
- 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.
Who cannot join
- women with a disability other than Down's syndrome
- Not agreeing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Down Syndrome
- Being tested
- Data collection
- Keywords
- Gynaecological follow-up, down syndrome, women
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynaecological follow-up
Presence or not of gynaecological follow-up
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muller Gaëlle, Principal investigator, Université de Reims Champagne-Ardenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117228
- Sponsor's protocol ID
- 2023_RIPH_016_Gyn-T21
- Acronym
- Gyn-T21
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France
- ClinicalTrials.gov ID
- NCT06117228
- Acronym / sponsor ID
- Gyn-T21 / 2023_RIPH_016_Gyn-T21
- Conditions
- Down Syndrome
- Keywords
- Gynaecological follow-up, down syndrome, women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim is to describe the gynaecological follow-up of women with Down syndrom in France.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with Down syndrome aged 18 to 30 | – | Other: Data collectionwomen aged 18 to 30 with Down syndrome, whether or not they were receiving medical care, who agreed to take part in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with Down syndrome, aged 18 to 30, whether or not they are being followed up in medical facilities in France.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- women with a disability other than Down's syndrome
- Not agreeing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection | Other | women with Down syndrome aged 18 to 30 |
Primary outcome
Gynaecological follow-up
Time frame: Day 0
Presence or not of gynaecological follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muller Gaëlle principal investigator
Université de Reims Champagne-Ardenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Université de Reims Champagne-Ardenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (0326913865 ext. +33, coralie.barbe@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gynaecological follow-up (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.