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

NCT06117228 | Unknown

• 1 other identifier: 2023_RIPH_016_Gyn-T21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Gynaecological follow-up; down syndrome; women

Outcome Measures

Primary Outcomes (1)

• Gynaecological follow-up

  Presence or not of gynaecological follow-up

  Day 0

Study Arms (1)

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

Data collection OTHER

Data collection

women with Down syndrome aged 18 to 30

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

Study Sites (1)

Ufr Medecine Urca

Reims, 51100, France

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Muller Gaëlle

  Université de Reims Champagne-Ardenne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbe Coralie, DR

CONTACT

0326913865; coralie.barbe@univ-reims.fr

CURRS CURRS

CONTACT

0326918822; curss@univ-reims.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

FR (1)