Pregnant Women s Views About the Ethics of Prenatal Whole... | NCT03105492

Studies
Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing

NCT03105492

Sponsor

National Human Genome Research Institute (NHGRI)

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

553Actual

Phase

Not provided

Conditions

Pregnant

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
17-HG-N080

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Actual

Primary Completion Date

Feb 12, 2018Actual

Completion Date

Apr 10, 2019Actual

First Submitted Date

Apr 7, 2017

First Submission Date that Met QC Criteria

Apr 7, 2017

First Posted Date

Apr 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

553Actual

Label	Type	Description	Intervention Names
Pregnant women		Women who are pregnant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:
Participants must be 18 years of age
Participants must be pregnant
Participants must speak English or Spanish

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant women.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin E Berkman, J.D.	National Human Genome Research Institute (NHGRI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INOVA Fairfax Hospital		Falls Church	Virginia	22042	United States