Aneuploidy, Down Syndrome, Pregnancy Early
Conditions
Keywords
prenatal, Screening, informed choice, randomized controlled trial
Brief 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. 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.
Interventions
BEHAVIORALEnhanced (intervention) education
See arm description
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 21 years or older * English speaking * had a viable singleton pregnancy below 14 weeks gestation
Exclusion criteria
* women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Informed choice | Day 0 | Outcome will be measured using the modified multidimensional measure of informed choice (MMIC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deliberation | Day 0 | Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale |
| Knowledge | Day 0 | Outcome will be measured using a 19-item validated true/false knowledge questionnaire. |
| Value-consistent behaviour | Day 0 | 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. |
| anxiety | Day 0 | Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items |
| Decisional Conflict | Day 0 | Decisional conflict was measured using a validated Decisional Conflict Scale (DCS) |
Countries
Singapore
Outcome results
None listed