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CompletedNCT03816423VPEUpdated May 19, 2020

Use of Videos to Improve Patient Knowledge on Prenatal Genetics

An interventional study of video in Aneuploidy and Birth Defect, sponsored by University of South Florida. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by University of South Florida · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Aneuploidy
  • Birth Defect

Keywords

  • patient education
  • genetic counseling
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In context

Aneuploidy

73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.

This study's enrollment of 106 is below the median of 200 across 34 interventional studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnancy, english or spanish-speaking

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • No intervention
    Traditional counseling

    Patients will undergo routine prenatal care visit with clinical practicioner only

  • Experimental
    video group

    Participants randomized to the intervention group (video education) will view the prenatal screening video "How to Decide About Prenatal Genetic Testing," followed by a routine prenatal appointment.

    Other: video

Interventions

  • Othervideo

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

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What researchers measure

Primary outcomes

  1. Knowledge score

    Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the "Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

    Time frame: same day for both groups

  2. Knowledge score change

    Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

    Time frame: same day for both groups

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Study locations

1 site
  • Genesis Healthpark- TGH
    Tampa, Florida 33609, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03816423
Collaborators
Tampa General Hospital
Responsible party
Sponsor
First posted
Jan 25, 2019
Start date
May 30, 2019
Primary completion
Jan 24, 2020
Completion
May 12, 2020
Last update
May 19, 2020

Study contacts

Karla Leavitt, MD, MPH
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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