AneuploidyEVANCT05492981
Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?
A study testing Enhanced (intervention) education in people with Aneuploidy and Down Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy, Down Syndrome, Pregnancy Early
- What is being tested?
- Enhanced (intervention) education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Jul 2021to 30 Jul 2022
- Phase
- Interventional
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 21 years or older
- English speaking
- had a viable singleton pregnancy below 14 weeks gestation
Who cannot join
- women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial
Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.
Read the detailed description
Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.
- Conditions
- Aneuploidy, Down Syndrome, Pregnancy Early
- Being tested
- Enhanced (intervention) education
- Keywords
- prenatal, Screening, informed choice, randomized controlled trial
- Medical subject headings
- Aneuploidy, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced (intervention) educationBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention was a 16-minute educational video created by the study investigators which provided information about Down syndrome, diagnostic tests and screening tests. The screening tests covered in the video included the triple test, the combined first trimester screen and non-invasive prenatal screening. Information about how and when each of the tests were performed, their detection rates and possible results and their interpretations were covered in the video. The video was viewed by several healthcare providers and experts in the field of prenatal screening before the commencement of this study to ensure that the content was appropriate and adequate. The intervention was viewed by subjects on a portable tablet in a quiet room in the antenatal clinic. Subjects were then invited to ask their doctor any questions that they may have had about the video during the clinic consult which followed. Receives: Behavioral: Enhanced (intervention) education |
| Control | No intervention | Women in the control group were counselled by the referring doctor regarding the aneuploidy screening options of FTS or NIPS, and provided information about the procedures involved for each test, their detection rates, cost, and possible results of testing. The use of a written information leaflet was available to doctors as an adjunct to providing this information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice
Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).
Measured: Day 0
Secondary outcomes (5)
Deliberation
Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale
Measured: Day 0
Knowledge
Outcome will be measured using a 19-item validated true/false knowledge questionnaire.
Measured: Day 0
Value-consistent behaviour
Attitudes towards testing options were assessed using a validated questionnaire and deemed to be value consistent if a participants had a positive attitude towards the test option that they chose, or a negative attitude towards all test options and chose not to test.
Measured: Day 0
anxiety
Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items
Measured: Day 0
Decisional Conflict
Decisional conflict was measured using a validated Decisional Conflict Scale (DCS)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start5 Jul 2021
- Primary completion24 Feb 2022
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AneuploidyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492981
- Sponsor's protocol ID
- 2020/01123
- Acronym
- EVA
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xian Lim KM, Lewis C, Wong HC, Chong GSL, Gosavi A, Choolani MA. Does an educational video for aneuploidy screening improve informed choice among pregnant women? A randomised controlled trial. Prenat Diagn. 2023 Jan;43(1):42-50. doi: 10.1002/pd.6279. Epub 2022 Dec 28.
PubMed 36550063
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05492981
- Acronym / sponsor ID
- EVA / 2020/01123
- Conditions
- Aneuploidy, Down Syndrome, Pregnancy Early
- Keywords
- prenatal, Screening, informed choice, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 9 Aug 2022 (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.
Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.
Detailed description
Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Enhanced (intervention) educationThe intervention was a 16-minute educational video created by the study investigators which provided information about Down syndrome, diagnostic tests and screening tests. The screening tests covered in the video included the triple test, the combined first trimester screen and non-invasive prenatal screening. Information about how and when each of the tests were performed, their detection rates and possible results and their interpretations were covered in the video. The video was viewed by several healthcare providers and experts in the field of prenatal screening before the commencement of this study to ensure that the content was appropriate and adequate. The intervention was viewed by subjects on a portable tablet in a quiet room in the antenatal clinic. Subjects were then invited to ask their doctor any questions that they may have had about the video during the clinic consult which followed. |
| Control | No intervention | –Women in the control group were counselled by the referring doctor regarding the aneuploidy screening options of FTS or NIPS, and provided information about the procedures involved for each test, their detection rates, cost, and possible results of testing. The use of a written information leaflet was available to doctors as an adjunct to providing this information. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 21 years or older
- English speaking
- had a viable singleton pregnancy below 14 weeks gestation
Key exclusion criteria (1 listed)
- women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy
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 |
|---|---|---|
| Enhanced (intervention) educationSee arm description | Behavioural | Intervention |
Primary outcome
Informed choice
Time frame: Day 0
Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).
5 secondary outcomes
Deliberation
Time frame: Day 0
Knowledge
Time frame: Day 0
Value-consistent behaviour
Time frame: Day 0
anxiety
Time frame: Day 0
Decisional Conflict
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 36550063Xian Lim KM, Lewis C, Wong HC, Chong GSL, Gosavi A, Choolani MA. Does an educational video for aneuploidy screening improve informed choice among pregnant women? A randomised controlled trial. Prenat Diagn. 2023 Jan;43(1):42-50. doi: 10.1002/pd.6279. Epub 2022 Dec 28.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced (intervention) education in people with Aneuploidy and Down Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Results are not available in the source record.
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?
Informed choice (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492981, which also lists 1 linked publication.
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 9 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.