Status:
COMPLETED
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
Lead Sponsor:
Premaitha Health
Conditions:
Aneuploidy, NIPT
Eligibility:
FEMALE
16+ years
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.
Detailed Description
A total of \~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
1632 Patients enrolled
Trial Details
Trial ID
NCT01472523
Start Date
April 1 2007
End Date
December 1 2019
Last Update
June 11 2020
Active Locations (1)
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1
Premaitha Health
Manchester, United Kingdom, M156SZ