Down SyndromeQUALI-21NCT04811534
Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21
An observational study of Down Syndrome, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 2 sitesReunion
- Study dates
- 28 Feb 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of a child born with Down Syndrome as of January 2019 living on the Reunion Island
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Reunion2 sites
CHU de la Réunion
Saint-Denis, 97400
CHU de la Réunion
Saint-Pierre, 97448
About this study
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
- Being tested
- Interview
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Mixed exploratory study, mixing a mainly qualitative study (semi-directed interviews) with a descriptive observational study (short self-questionnaire of the interviewees).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start28 Feb 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811534
- Sponsor's protocol ID
- 2021/CHU/06
- Acronym
- QUALI-21
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21
- ClinicalTrials.gov ID
- NCT04811534
- Acronym / sponsor ID
- QUALI-21 / 2021/CHU/06
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of a child born with Down Syndrome as of January 2019 living on the Reunion Island
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewMixed exploratory study, mixing a mainly qualitative study (semi-directed interviews) with a descriptive observational study (short self-questionnaire of the interviewees). | Behavioural | – |
Primary outcome
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.
2 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.