We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Post-mortem Genetic Testing

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.
ClinicalTrials.gov Identifier: NCT01120886
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : April 22, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Condition or disease
Cardiac Ion Channelopathy

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
Study Start Date : January 2011
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

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

Biospecimen Retention:   Samples With DNA
Skin and muscle

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 Posted: May 11, 2010    Key Record Dates
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:
Pathologic Processes