Use of Videos to Improve Patient Knowledge on Prenatal Genetics

Brief Title

Use of Videos to Improve Patient Knowledge on Prenatal Genetics

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Knowledge score


Condition

Aneuploidy

Intervention

video

Study Arms / Comparison Groups

 Traditional counseling
Description:  Patients will undergo routine prenatal care visit with clinical practicioner only

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

106

Start Date

May 30, 2019

Completion Date

May 12, 2020

Primary Completion Date

January 24, 2020

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Karla Leavitt, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03816423

Organization ID

00035994


Responsible Party

Sponsor

Study Sponsor

University of South Florida

Collaborators

 Tampa General Hospital

Study Sponsor

Karla Leavitt, MD, MPH, Principal Investigator, University of South Florida


Verification Date

March 2020