Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

Down Syndrome Clinical Trial

— EVA  

Official title:

Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05492981
• Other study ID #: 2020/01123
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2022
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 286
• Est. completion date: July 30, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Pregnancy Early

Intervention

Behavioral:
• Enhanced (intervention) education
See arm description

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Informed choice	Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).	Day 0
Secondary	Deliberation	Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale	Day 0
Secondary	Knowledge	Outcome will be measured using a 19-item validated true/false knowledge questionnaire.	Day 0
Secondary	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.	Day 0
Secondary	anxiety	Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items	Day 0
Secondary	Decisional Conflict	Decisional conflict was measured using a validated Decisional Conflict Scale (DCS)	Day 0