Study Stopped
Awaiting verification of assay
Development of an Optimal Approach to Return of Results for Next-generation Sequencing for Prenatal Diagnosis
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2019
CompletedJune 6, 2019
June 1, 2019
4.7 years
September 24, 2014
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in maternal mood (focused on assessment of depression)
Compare mood measured by EPDS between enrollment and 3 months after completion of pregnancy
At enrollment and 3 months after completion of pregnancy (expected to be 8 months after enrollment)
Change in paternal mood (focused on assessment of depression)
Compare mood measured by EPDS between enrollment and 3 months after completion of pregnancy
At enrollment and 3 months after completion of pregnancy (expected to be 8 months after enrollment)
Secondary Outcomes (2)
Change in maternal mood (focused on assessment of anxiety)
At enrollment and 3 months after completion of pregnancy (expected to be 8 months after enrollment)
Change in paternal mood (focused on assessment of anxiety)
At enrollment and 3 months after completion of pregnancy (expected to be 8 months after enrollment)
Study Arms (2)
Control Group
ACTIVE COMPARATORAmniocentesis will be performed, Whole Genome Sequencing will not be performed, and psychosocial assessment will be performed.
Intervention Group
EXPERIMENTALAmniocentesis will be performed, Whole Genome Sequencing will be performed if the karyotype is normal, and psychosocial assessment will be performed.
Interventions
Whole genome sequencing in a CLIA lab and return of results.
Note: this is being performed on all subjects as a clinical (not research) procedure
Use of EPDS and STAI for assessment of maternal and paternal mood
Eligibility Criteria
You may qualify if:
- Subject(s) 18 years or older (both mom and father of baby (FOB)
- Subject is undergoing prenatal testing for a major fetal anomaly
You may not qualify if:
- Mothers or fathers of the affected fetus are under the age of 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD Health Sciences, Fetal Care and Genetics
San Diego, California, 92121, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD/PhD
Study Record Dates
First Submitted
September 24, 2014
First Posted
October 3, 2014
Study Start
October 1, 2014
Primary Completion
June 4, 2019
Study Completion
June 4, 2019
Last Updated
June 6, 2019
Record last verified: 2019-06