NCT01120886

Brief Summary

This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

May 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

May 7, 2010

Last Update Submit

April 19, 2013

Conditions

Cardiac Ion Channelopathy

Keywords

Ion channelopathy,Still birthSudden death

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiac ion channelopathy mutation

    6 months

Secondary Outcomes (1)

  • Incidence of cardiac ion channelopathy in 1st degree relatives of index case

    12 months

Eligibility Criteria

Age24 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Unexplained still births

You may qualify if:

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

You may not qualify if:

  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Great Ormond Street Hospital

London, United Kingdom

Location

Southampton University Hospital

Southampton, United Kingdom

Location

Related Publications (1)

  • Munroe PB, Addison S, Abrams DJ, Sebire NJ, Cartwright J, Donaldson I, Cohen MM, Mein C, Tinker A, Harmer SC, Aziz Q, Terry A, Struebig M, Warren HR, Vadgama B, Fowler DJ, Peebles D, Taylor AM, Lally PJ, Thayyil S. Postmortem Genetic Testing for Cardiac Ion Channelopathies in Stillbirths. Circ Genom Precis Med. 2018 Jan;11(1):e001817. doi: 10.1161/CIRCGEN.117.001817. Epub 2018 Jan 11.

    PMID: 29874177DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Skin and muscle

MeSH Terms

Conditions

StillbirthDeath, Sudden

Condition Hierarchy (Ancestors)

Fetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neonatologist

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 11, 2010

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

GB(2)