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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de la Réunion, Saint-Denis, Reunion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview

Behavioral

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

Primary outcomes

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

Time frame: 1 day

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.

Secondary outcomes

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

Time frame: 1 day

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.
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

Time frame: 1 day

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: QUALI-21

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 23, 2021
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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