An interventional study of Enhanced (intervention) education in Aneuploidy, Down Syndrome and Pregnancy Early, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to female participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Screening
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.
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.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's enrollment of 286 is above the median of 200 across 34 interventional studies indexed under Aneuploidy.
Browse Aneuploidy studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Enhanced (intervention) education
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.
See arm description
Informed choice
Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).
Time frame: Day 0
Deliberation
Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale
Time frame: Day 0
Knowledge
Outcome will be measured using a 19-item validated true/false knowledge questionnaire.
Time frame: 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.
Time frame: Day 0
anxiety
Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items
Time frame: Day 0
Decisional Conflict
Decisional conflict was measured using a validated Decisional Conflict Scale (DCS)
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Feb 2022, 7 months.
Of 19 interventional studies with no phase under Aneuploidy, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University Hospital, Singapore →