NCT05492981

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aneuploidy
• Down Syndrome
• Pregnancy Early

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced (intervention) education	See arm description

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-02-24
• Completion: 2022-07-30
• First posted: 2022-08-09
• Last updated: 2022-08-09

Locations

1 site across 1 country: Singapore