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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit. |
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| Experimental | Experimental | The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced (experimental) education | Behavioral | See arm description. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Parobek | Department of OB/GYN, Women and Infants Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351406 | Derived | Parobek CM, Thorsen MM, Has P, Lorenzi P, Clark MA, Russo ML, Lewkowitz AK. Video education about genetic privacy and patient perspectives about sharing prenatal genetic data: a randomized trial. Am J Obstet Gynecol. 2022 Jul;227(1):87.e1-87.e13. doi: 10.1016/j.ajog.2022.03.047. Epub 2022 Mar 26. | |
| 34051169 | Derived |
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Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.
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De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.
De-identified study data will be shared with researchers upon request.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2025 | |
| Reset | Apr 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2025 | Apr 18, 2025 |
| ID | Term |
|---|---|
| D000782 | Aneuploidy |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Standard (control) education. |
| Behavioral |
See arm description. |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Parobek CM, Has P, Lorenzi P, Russo ML, Clark MA, Lewkowitz AK. What test did I have? Patient uncertainty about prenatal genetic screening. Am J Obstet Gynecol. 2021 Sep;225(3):341-342. doi: 10.1016/j.ajog.2021.05.030. Epub 2021 May 27. No abstract available. |