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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Behavioral: Interview

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Reunion
  • Saint-Denis, Reunion, 97400
    • CHU de la Réunion
  • Saint-Pierre, Reunion, 97448
    • CHU de la Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Parents:

• with normal/negative prenatal screening (False positive)
• minors at the time of inclusion
• under guardianship or legal protection
• with a pathology preventing the interviews from taking place

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Verbal data collection (verbatim) during individual semi-structured interviews of parents, by a French and Creole speaking interviewer, trained in qualitative interviews with an audio recording, followed by a written transcription of these verbatims. Women and their partners will be interviewed individually. For this criterion, the parents interviewed will be adults living in Reunion who have or have not wished to have a prenatal diagnosis of Down Syndrome for their child.	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	Socio-demographic characteristics will be collected through a self-administered questionnaire, distributed after the individual qualitative interview. The questionnaire consists of 5 parts (socio-demographic data, health insurance, family, housing and religion) and 18 questions. The time required to complete the questionnaire is 10 minutes. This questionnaire will make it possible to describe the population surveyed on certain variables and to ensure that a reasoned sample (heterogeneous population) has been taken from the parents.	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Congenital Abnormalities; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Down Syndrome; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 2021/CHU/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No