Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2017-01-12
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
OTHER
NONE
Study Groups
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Video education
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.
Video education
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 .
Usual care
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).
No interventions assigned to this group
Interventions
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Video education
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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* Less than 18 years of age
* Gestational age greater than 20 weeks
* Multiple gestation
* Aneuploidy testing in current pregnancy
18 Years
FEMALE
No
Sponsors
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United States Naval Medical Center, San Diego
FED
Responsible Party
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Monica Lutgendorf
Principal Investigator
Locations
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Naval Medical Center San Diego
San Diego, California, United States
Countries
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Other Identifiers
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NMCSD.2016.0070
Identifier Type: -
Identifier Source: org_study_id
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