PregnantNCT03105492
Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
An observational study of Pregnant, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnant
- How many people
- 553 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 10 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women.
Who may be able to join
- Participants must be 18 years of age
- Participants must be pregnant
- Participants must speak English or Spanish
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Background:
Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. They want to know why and under what circumstances women would or would not want the data.
Read more
Objective:
To explore the views of pregnant women about possible use of PWGS. To find out whether they would want different categories of genetic data, and how they would use such findings.
Eligibility:
Women ages 18 and older who pregnant and speak English or Spanish
Design:
Participants will be recruited by their doctors.
Participants will take a survey about their views of PWGQ. They may take it online or on paper.
Read the detailed description
The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of ethical concerns given the massive amounts of genetic information that expecting parents will be able to learn about their baby. This project involves a cross-sectional quantitative survey of pregnant women to explore whether they want access to the kinds of information provided by PWGS, why and under what circumstances. The survey will address questions such as: What sorts of information do pregnant women want to know about their baby, and why? What, if anything, would they do with the information? What kind of guidance would pregnant women like from their medical team regarding fetal genetic testing? Given the range of practical and ethical challenges posed by PWGS, our data will inform practitioners approaches towards PWGS as the technology develops and becomes more widely available. It is imperative that government regulators and professional societies take into account the views of people directly affected by any policies that are created - including patients themselves - before crafting rules for whether, when and how to utilize PWGS.
- Conditions
- Pregnant
- Keywords
- Prenatal Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women who are pregnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views of pregnant women
This study seeks to explore the views of pregnant women about the hypothetical utility of PWGS, whether they would want different categories of genetic information, and how they would anticipate using such findings.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start15 Jun 2017
- Primary completion12 Feb 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Benjamin E Berkman, J.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105492
- Sponsor's protocol ID
- 999917080
- Other IDs
- 17-HG-N080
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
- ClinicalTrials.gov ID
- NCT03105492
- Acronym / sponsor ID
- 999917080
- Conditions
- Pregnant
- Keywords
- Prenatal Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. They want to know why and under what circumstances women would or would not want the data.
Objective:
To explore the views of pregnant women about possible use of PWGS. To find out whether they would want different categories of genetic data, and how they would use such findings.
Eligibility:
Women ages 18 and older who pregnant and speak English or Spanish
Design:
Participants will be recruited by their doctors.
Participants will take a survey about their views of PWGQ. They may take it online or on paper.
Detailed description
The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of ethical concerns given the massive amounts of genetic information that expecting parents will be able to learn about their baby. This project involves a cross-sectional quantitative survey of pregnant women to explore whether they want access to the kinds of information provided by PWGS, why and under what circumstances. The survey will address questions such as: What sorts of information do pregnant women want to know about their baby, and why? What, if anything, would they do with the information? What kind of guidance would pregnant women like from their medical team regarding fetal genetic testing? Given the range of practical and ethical challenges posed by PWGS, our data will inform practitioners approaches towards PWGS as the technology develops and becomes more widely available. It is imperative that government regulators and professional societies take into account the views of people directly affected by any policies that are created - including patients themselves - before crafting rules for whether, when and how to utilize PWGS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Women who are pregnant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women.
Key inclusion criteria (3 listed)
- Participants must be 18 years of age
- Participants must be pregnant
- Participants must speak English or Spanish
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Views of pregnant women
Time frame: at baseline
This study seeks to explore the views of pregnant women about the hypothetical utility of PWGS, whether they would want different categories of genetic information, and how they would anticipate using such findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin E Berkman, J.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views of pregnant women (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.