A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
IONA
1 other identifier
observational
1,632
1 country
1
Brief Summary
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 11, 2020
June 1, 2020
10.8 years
October 11, 2011
June 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of method of novel analysis for Aneuploidy
Analysis of maternal blood by a selective amplification of fetal DNA over maternal DNA within that sample. Patients to be followed up for 1 year.
2013 Approx
Secondary Outcomes (1)
Optimization of existing methods for maximising ffDNA
up to July 2019
Study Arms (2)
Controls
Aneuploidy
T13, 18, 21 and other chromosomal abnormalities yet to be determined
Eligibility Criteria
Mothers attending clinic for routine screening. Followed up at around 1 years duration.
You may qualify if:
- Patient/subject is willing and able to give informed consent for participation in the study.
- Female, aged 16 years or above.
- Currently pregnant at time of entry to the study.
- Pregnancy having been identified as 'high-risk' by screening test.
You may not qualify if:
- The patient/subject may not enter the study if ANY of the following apply:
- The participant herself has Down's Syndrome or other chromosomal abnormality.
- Children under 16
- Adults with learning disabilities
- Adults who are unconscious or very severely ill
- Adults who have a terminal illness
- Adults in emergency situations
- Adults suffering from a mental illness
- Adults with dementia
- Prisoners
- Young offenders
- Adults who are unable to consent for themselves
- Any person considered to have a particularly dependent relationship with investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Premaitha Healthlead
Study Sites (1)
Premaitha Health
Manchester, M156SZ, United Kingdom
Biospecimen
Maternal peripheral blood samples taken in EDTA with that required for existing analysis. Approx 1ml of fluid from amniocentesis/chorionic villus sampling is taken additional. Patients will be followed up for 1 year after sample taken.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Kelly, MBBS
National Health Service, United Kingdom
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2011
First Posted
November 16, 2011
Study Start
April 1, 2007
Primary Completion
February 1, 2018
Study Completion
December 1, 2019
Last Updated
June 11, 2020
Record last verified: 2020-06