Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21

NCT04811534 | Completed

• 1 other identifier: 2021/CHU/06
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

According to data from French congenital malformation registries, the prevalence of Down Syndrome (DS) in 2017 (live births and medical termination of pregnancy (MToP)) in Reunion Island was the lowest in France (23.04 per 10,000 births), notably in relation to a young maternal age. However, if we look at live births, Reunion Island has the highest prevalence of DS in France (12.24 vs. 5.81 per 10,000 births), despite a well organized prenatal diagnosis (PND). In fact, the use of MToP in this context is the lowest in France (10.8 vs 26.3 per 10 000 births). Local specificities may have an impact on the choice of patients to undergo or not undergo a MToP in the context of PND of DS and explain why the rate of recourse to MToP is the lowest in France. To date, no qualitative study exploring the reasons why women and their partners do not undergo a MToP in the context of DS has been conducted in Reunion Island. Thus, the main hypothesis is that the low recourse to MToP following PND of DS in Reunion Island could be explained by the beliefs, values or choices of Reunion Island women and their partners during pregnancy in relation to a specific family, socio-cultural and economic context.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Reasons and motivations that lead parents living in Reunion Island not to carry out a medical termination of pregnancy, following a prenatal diagnosis of Down Syndrome

  Collecting verbal data (verbatim) during individual semi-directive interviews with a French and Creole-speaking interviewer, trained in qualitative interviews with an audio recording, and then a written transcription of these verbatims. Women and their partners will be interviewed individually. The parents will be asked to recount chronologically the course of the pregnancy from the preconceptional period to the birth, focusing on their experiences during each stage of this period. Given the sensitivity of the subject, individual interviews are preferred to focus groups.

  1 day

Secondary Outcomes (2)

• Reasons that lead parents living in Reunion to carry out or not a prenatal diagnosis, among women who have had a child with Down Syndrome

  1 day

• Socio-demographic characteristics of the parents and the pregnancy follow-up data of the women interviewed using a questionnaire and REMACOR data from the computerized medical record

  1 day

Interventions

Interview BEHAVIORAL

Mixed exploratory study, mixing a mainly qualitative study (semi-directed interviews) with a descriptive observational study (short self-questionnaire of the interviewees).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of a child born with Down Syndrome as of January 2019 living on the Reunion Island

You may qualify if:

• Parents:
• of a child born alive with Down Syndrome as of January 1, 2019 and registered within REMACOR
• living on the island of Reunion at the time of birth
• having a good understanding of French and/or Creole
• having given their written consent to the study

You may not qualify if:

• Parents:
• with normal/negative prenatal screening (False positive)
• under guardianship or legal protection
• with a pathology preventing the interviews from taking place

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (2)

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location

CHU de la Réunion

Saint-Pierre, 97448, Reunion

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Interviews as Topic

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)

Data Collection; 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 Design

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

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: February 28, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (2)