Back to resultsClinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies (TWIN)
Primary Purpose
Down Syndrome, Patau Syndrome, Edward's Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional screening trial for Down Syndrome
Eligibility Criteria
Inclusion Criteria:
- Currently pregnant with twin foetuses at time of entry to study
- Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
- If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.
Exclusion Criteria:
- Participant herself has down syndrome or other chromosomal abnormality
Sites / Locations
- Premaitha Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Low Risk
High Risk
Arm Description
350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.
150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant.
Outcomes
Primary Outcome Measures
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03200041
Brief Title
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Acronym
TWIN
Official Title
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Premaitha Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.
Detailed Description
350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Patau Syndrome, Edward's Syndrome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Risk
Arm Type
Other
Arm Description
350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.
Arm Title
High Risk
Arm Type
Other
Arm Description
150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant.
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
20 ml blood sample taken from vein in arm
Primary Outcome Measure Information:
Title
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
Description
IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Currently pregnant with twin foetuses at time of entry to study
Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.
Exclusion Criteria:
Participant herself has down syndrome or other chromosomal abnormality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asma Khalil, MBBS
Organizational Affiliation
National Health Service, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Premaitha Health
City
Manchester
ZIP/Postal Code
M15 6SZ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IONA Test results being given to patients
Learn more about this trial
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
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