Video Education for Prenatal Testing Choices

NCT04062968 | Completed

• 1 other identifier: NMCSD.2016.0070
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the investigator's study is to assess the effect of a standardized prenatal testing educational video on the use of prenatal genetic testing and decision-making.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• screening uptake rates

  Genetic screening

  24-36 weeks gestation

Secondary Outcomes (4)

• Invasive diagnostic test rates

  24-36 weeks gestation

• Participant knowledge about prenatal testing

  up to 20 weeks gestation

• Decisional conflict

  up to 20 weeks gestation

• Decisonal regret

  up to 20 weeks gestation

Study Arms (2)

Video education

EXPERIMENTAL

Women randomized to the intervention group (video education) will view the prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit.

Other: Video education

Usual care

NO INTERVENTION

Women randomized to the control group will receive routine prenatal care with no additional study intervention other than completion of the study related surveys at baseline (initial prenatal testing).

Interventions

Video education OTHER

Prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .

Video education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age
• Gestational age less than or equal to 20 weeks
• Singleton gestation
• Not completed aneuploidy screening in this pregnancy
• Available to watch the 15 minute video
• Ability to read, write, and understand English

You may not qualify if:

• Pregnant women not eligible for care at Military Treatment Facility
• Less than 18 years of age
• Gestational age greater than 20 weeks
• Multiple gestation
• Aneuploidy testing in current pregnancy

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to video education or usual care. Randomization will be completed using a random number table. Women randomized to the intervention group (video education) will view the prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit. Women randomized to the control group will receive routine prenatal care with no additional study intervention other than completion of the study related surveys at baseline (initial prenatal testing).

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 20, 2019
• Study Start: January 12, 2017
• Primary Completion: January 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)