search
Back to results

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

Primary Purpose

Aneuploidy, Down Syndrome, Pregnancy Early

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Enhanced (intervention) education
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Aneuploidy focused on measuring prenatal, Screening, informed choice, randomized controlled trial

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Informed choice
Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).

Secondary Outcome Measures

Deliberation
Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale
Knowledge
Outcome will be measured using a 19-item validated true/false knowledge questionnaire.
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.
anxiety
Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items
Decisional Conflict
Decisional conflict was measured using a validated Decisional Conflict Scale (DCS)

Full Information

First Posted
July 31, 2022
Last Updated
August 5, 2022
Sponsor
National University Hospital, Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT05492981
Brief Title
Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?
Acronym
EVA
Official Title
Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploidy, Down Syndrome, Pregnancy Early
Keywords
prenatal, Screening, informed choice, randomized controlled trial

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced (intervention) education
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Informed choice
Description
Outcome will be measured using the modified multidimensional measure of informed choice (MMIC).
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Deliberation
Description
Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale
Time Frame
Day 0
Title
Knowledge
Description
Outcome will be measured using a 19-item validated true/false knowledge questionnaire.
Time Frame
Day 0
Title
Value-consistent behaviour
Description
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
Title
anxiety
Description
Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items
Time Frame
Day 0
Title
Decisional Conflict
Description
Decisional conflict was measured using a validated Decisional Conflict Scale (DCS)
Time Frame
Day 0

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs