Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?
- Conditions
- Down SyndromeAneuploidyPregnancy Early
- Interventions
- Behavioral: Enhanced (intervention) education
- Registration Number
- NCT05492981
- Lead Sponsor
- National University Hospital, Singapore
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 286
- aged 21 years or older
- English speaking
- had a viable singleton pregnancy below 14 weeks gestation
- women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Enhanced (intervention) education 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.
- Primary Outcome Measures
Name Time Method Informed choice Day 0 Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore