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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04420858
Other study ID # 1500909-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 21, 2020
Est. completion date October 16, 2020

Study information

Verified date November 2020
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes.


Description:

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants' maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate. Volunteers will be randomized to receive either standard education about prenatal genetic testing or standard education plus additional education about federal genetic privacy protections. Next, the participants view the educational materials to which they were randomized. Finally, all volunteers will take the same survey, which will assess baseline demographic variables as well as their knowledge of and attitudes toward broad sharing of data obtained from prenatal genetic testing. Once finished with the survey, volunteers will have completed their participation in this study.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date October 16, 2020
Est. primary completion date October 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant patients undergoing a scheduled L2 ultrasound at the Women and Infants Prenatal Diagnosis Center (PDC) - Singleton pregnancies - English speaking - Results available from cell-free DNA screening for this pregnancy Exclusion Criteria: - Prior L2 ultrasound at the PDC during the current pregnancy (to avoid test-retest or multiple approach) - Prior participation in this study - Gestational age <17'0 weeks or >23'6 weeks - Suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation) - Unscheduled / add-on L2 ultrasounds

Study Design


Intervention

Behavioral:
Enhanced (experimental) education
See arm description.
Standard (control) education.
See arm description.

Locations

Country Name City State
United States Women and Infants Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge about broad sharing of genetic data for non-clinical research purposes Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient knowledge about the potential sharing of their genetic data for non-clinical research purposes? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Primary Acceptability of broad sharing of genetic data for non-clinical research purposes Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of laboratory-initiated sharing of their de-identified genetic data for non-clinical purposes? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Acceptability of retention of genetic data for non-clinical purposes Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of retaining their de-identified genetic data to potentially use it for non-clinical purposes? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Acceptability of use of genetic data for non-clinical purposes Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of using their de-identified genetic data for non-clinical purposes such as research and development? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Knowledge and understanding of aneuploidy screening and results Are patients aware that they underwent aneuploidy screening with cell-free fetal DNA (cfDNA)? Are they aware of their results? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Knowledge and understanding of carrier testing and results Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patients aware that they underwent carrier testing? Are they aware of their results? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Assess maternal acceptance of each of these outcomes. Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Maternal rationale for pursuing cfDNA Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What prompted patient to pursue cfDNA testing? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Maternal knowledge of different commercial cfDNA providers Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patents who have undergone cfDNA testing aware that multiple companies offer this service? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies. Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening and are participating in this study understand these topics? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
Secondary Maternal perceptions of the de-identifiability of genetic data Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening believe that deidentified genetic information is not re-identifiable? Outcome will be measured on the Likert scale. This outcome will be assessed immediately after exposure to education (day 0)
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