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Clinical Trials/NCT04811534
NCT04811534
Completed
Not Applicable

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

Centre Hospitalier Universitaire de la Réunion2 sites in 1 country28 target enrollmentFebruary 28, 2022
ConditionsDown Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Down Syndrome
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
28
Locations
2
Primary Endpoint
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
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2022
End Date
April 30, 2024
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

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

  • 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)
  • 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)

Study Sites (2)

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