- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120886
Post-mortem Genetic Testing
April 19, 2013 updated by: Sudhin Thayyil, Thayyil, Sudhin
Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Great Ormond Street Hospital
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Southampton, United Kingdom
- Southampton University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 9 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Unexplained still births
Description
Inclusion Criteria:
- Unexplained still births,
- No cause of death after detailed autopsy
Exclusion Criteria:
- Lack of parental consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cardiac ion channelopathy mutation
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cardiac ion channelopathy in 1st degree relatives of index case
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 7, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 11, 2010
Study Record Updates
Last Update Posted (Estimate)
April 22, 2013
Last Update Submitted That Met QC Criteria
April 19, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 48699
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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