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Completed

NCT Number: NCT04062968

Video Education for Prenatal Testing Choices

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

This is a prospective randomized trial of video education on prenatal testing vs. usual care, with the goal to assess women's prenatal testing choices, understanding of testing options and decisional conflict and regret. Participants will be recruited from a convenience sample of patients presenting for prenatal care at Naval Medical Center San Diego (NMCSD).

While receiving prenatal care at NMCSD, all women are offered the option of screening for aneuploidy (serum screen (with or without nuchal translucency ultrasound) or cell free DNA testing) or diagnostic testing (chorionic villous sampling or amniocentesis) or no testing in pregnancy.

After providing consent, 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. The educational video was created with input from clinicians including licensed genetic counselors, obstetricians, maternal fetal medicine physicians, and patients. Extensive testing and reviewing was completed to ensure adequate comprehension by a wide range of audiences and minimize counseling bias. 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). Current national guidelines recommend offering all women prenatal diagnosis and prenatal screening at the beginning of the pregnancy.1

The primary outcome for this study will be screening uptake rates, and will be based on review of the patient's electronic medical record. Secondary outcomes will include invasive diagnostic test rates, participant knowledge about testing (as assessed using the Maternal Serum Screening Knowledge Questionnaire,2 and decisional conflict (as assessed by the Decisional Conflict Scale) and decisional regret (as assessed by the Decision Regret Scale). These assessments will be conducted at time of prenatal testing (< 20 weeks). (Appendix A)

The study questionnaire will include a check box for participants to indicate if they would be willing to participate in a follow on qualitative study to assess participant's personal experience related to their method of education about prenatal testing. This component of the study will aim to determine personal and social reasoning behind their decisions, and to further explore their experience, beliefs and behaviors. Interested participants from each group (both intervention and control) will be contacted to arrange a telephone or in person interview. (Appendix C) Participants will be interviewed in person or over the phone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 .

Primary outcomes

  1. screening uptake rates

    Time frame: 24-36 weeks gestation

    Genetic screening

Secondary outcomes

  1. Invasive diagnostic test rates

    Time frame: 24-36 weeks gestation

    Diagnostic testing such as Chorinonic Villus Sampling and amniocentesis

  2. Participant knowledge about prenatal testing

    Time frame: up to 20 weeks gestation

    Assessed by using the Maternal Serum Screening knowledge Questionnaire. Scores range from 0 to 15, reflecting the number of correct answers. A score of zero would indicate zero correct answers, where a score of 15 would indicate all answers were correct. Higher scores are considered better outcome indicating higher knowledge.

  3. Decisional conflict

    Time frame: up to 20 weeks gestation

    Assessed by the Decisional Conflict Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional conflict. Subscale Decisional Uncertainty score range 3 to 15. Subscale Percieved Effective Decision range 4 to 20.

  4. Decisonal regret

    Time frame: up to 20 weeks gestation

    Assessed by the Decisional Regret Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional regret. Decisional Regret scores range 0 to 100.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

The Effect of Standardized Video Education on Prenatal Genetic Testing Choices, Decisional Conflict, and Decisional Regret

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2019
Registry last updated
Aug 25, 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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