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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03105492
Other study ID # 999917080
Secondary ID 17-HG-N080
Status Completed
Phase
First received
Last updated
Start date June 15, 2017
Est. completion date April 10, 2019

Study information

Verified date April 2019
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 553
Est. completion date April 10, 2019
Est. primary completion date February 12, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility - INCLUSION CRITERIA:

- Participants must be 18 years of age

- Participants must be pregnant

- Participants must speak English or Spanish

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States INOVA Fairfax Hospital Falls Church Virginia

Sponsors (1)

Lead Sponsor Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at baseline
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