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Completed

NCT Number: NCT03816423

Use of Videos to Improve Patient Knowledge on Prenatal Genetics

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.

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Key information

Conditions

Aneuploidy Birth Defect Chromosome Aberrations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Healthpark- TGH

Tampa, Florida, 33609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video

Other

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

Primary outcomes

  1. Knowledge score

    Time frame: same day for both groups

    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)

  2. Knowledge score change

    Time frame: same day for both groups

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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Tampa General Hospital

Registry information

Official study title

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

Acronym: VPE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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