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Development of an Optimal Approach to Return of Results for Next-generation Sequencing for Prenatal Diagnosis

NCT02255825 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-06

No results posted yet for this study

Summary

To gain knowledge about how patients undergoing prenatal diagnosis for a fetal abnormality understand and react to Whole Genome Sequencing (WGS) testing, so that the investigators can develop more ethical and responsible approach to patient education, counseling, and return of results for patients.

Conditions

  • Major Fetal Anomaly

Interventions

GENETIC

Whole Genome Sequencing

Whole genome sequencing in a CLIA lab and return of results.

PROCEDURE

Amniocentesis

Note: this is being performed on all subjects as a clinical (not research) procedure

OTHER

Psychosocial assessment

Use of EPDS and STAI for assessment of maternal and paternal mood

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-06-04
Completion
2019-06-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255825 on ClinicalTrials.gov