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Use of Videos to Improve Patient Knowledge on Prenatal Genetics

The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03816423
Acronym
VPE
Enrollment
106
Registered
2019-01-25
Start date
2019-05-30
Completion date
2020-05-12
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy, Birth Defect

Keywords

patient education, genetic counseling

Brief summary

This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options.

Detailed description

During pregnancy, women are routinely counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing options to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. A standardized educational video on prenatal screening may enhance a patient's understanding and knowledge of testing and support more informed decisions. The objective of this study is to evaluate and compare patient knowledge scores on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

Interventions

OTHERvideo

Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.

Sponsors

Tampa General Hospital
CollaboratorOTHER
University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video. All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit. Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled How to decide about prenatal genetic testing.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* pregnancy, english or spanish-speaking

Exclusion criteria

* minors \<18 years old, * \> 21 completed weeks of gestational age, * prior genetic counseling during current pregnancy * fetus with known ultrasound abnormality

Design outcomes

Primary

MeasureTime frameDescription
Knowledge scoresame day for both groupsEvaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the Maternal Serum Screening Knowledge Score Questionnaire (MSSKQ)
Knowledge score changesame day for both groupsCompare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire (MSSKQ)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026