NCT05492981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
Last Updated

August 9, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

July 31, 2022

Last Update Submit

August 5, 2022

Conditions

AneuploidyDown SyndromePregnancy Early

Keywords

prenatalScreeninginformed choicerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Informed choice

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

    Day 0

Secondary Outcomes (5)

  • Deliberation

    Day 0

  • Knowledge

    Day 0

  • Value-consistent behaviour

    Day 0

  • anxiety

    Day 0

  • Decisional Conflict

    Day 0

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced (intervention) education

Control

NO INTERVENTION

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.

Interventions

Enhanced (intervention) educationBEHAVIORAL

See arm description

Intervention

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 21 years or older
  • English speaking
  • had a viable singleton pregnancy below 14 weeks gestation

You may not qualify if:

  • women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

  • Xian Lim KM, Lewis C, Wong HC, Chong GSL, Gosavi A, Choolani MA. Does an educational video for aneuploidy screening improve informed choice among pregnant women? A randomised controlled trial. Prenat Diagn. 2023 Jan;43(1):42-50. doi: 10.1002/pd.6279. Epub 2022 Dec 28.

    PMID: 36550063DERIVED

MeSH Terms

Conditions

AneuploidyDown Syndrome

Interventions

MethodsEducational Status

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Investigative TechniquesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 9, 2022

Study Start

July 5, 2021

Primary Completion

February 24, 2022

Study Completion

July 30, 2022

Last Updated

August 9, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)