Use of Videos to Improve Patient Knowledge on Prenatal Genetics

Aneuploidy Clinical Trial

— VPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816423
• Other study ID #: 00035994
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: March 2020
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 12, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Birth Defect
• Congenital Abnormalities

Intervention

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

Locations

Country	Name	City	State
United States	Genesis Healthpark- TGH	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Tampa General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	same day for both groups
Primary	Knowledge score change	Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)	same day for both groups