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Post-mortem Genetic Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120886
First Posted: May 11, 2010
Last Update Posted: April 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin
  Purpose
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Condition
Cardiac Ion Channelopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births

Resource links provided by NLM:


Further study details as provided by Sudhin Thayyil, Thayyil, Sudhin:

Primary Outcome Measures:
  • Incidence of cardiac ion channelopathy mutation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Incidence of cardiac ion channelopathy in 1st degree relatives of index case [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Skin and muscle

Estimated Enrollment: 100
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Unexplained still births
Criteria

Inclusion Criteria:

  • Unexplained still births,
  • No cause of death after detailed autopsy

Exclusion Criteria:

  • Lack of parental consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120886


Locations
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Thayyil, Sudhin
  More Information

Additional Information:
Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT01120886     History of Changes
Other Study ID Numbers: 48699
First Submitted: May 7, 2010
First Posted: May 11, 2010
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Sudhin Thayyil, Thayyil, Sudhin:
Ion channelopathy,
Still birth
Sudden death

Additional relevant MeSH terms:
Channelopathies
Pathologic Processes