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

Brief Title

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

Official Title

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


Study Type

Interventional


Primary Outcome

Informed choice

Secondary Outcome

 Deliberation

Condition

Aneuploidy

Intervention

Enhanced (intervention) education

Study Arms / Comparison Groups

 Intervention
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

286

Start Date

July 5, 2021

Completion Date

July 30, 2022

Primary Completion Date

February 24, 2022

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
      

Gender

Female

Ages

21 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT05492981

Organization ID

2020/01123


Responsible Party

Sponsor

Study Sponsor

National University Hospital, Singapore


Study Sponsor

, , 


Verification Date

July 2022