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Post-mortem Genetic Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin
ClinicalTrials.gov Identifier:
NCT01120886
First received: May 7, 2010
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:
  • Incidence of cardiac ion channelopathy mutation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of cardiac ion channelopathy in 1st degree relatives of index case [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   24 Weeks to 42 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Institute for Women's Health  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT01120886     History of Changes
Other Study ID Numbers: 48699
Study First Received: May 7, 2010
Last Updated: April 19, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Channelopathies
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013