Clinical trial NCT04811534: Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21
Official title: Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of a child born with Down Syndrome as of January 2019 living on the Reunion Island

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: 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
timeFrame: 1 day
measure: 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
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
References: