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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03200041
Other study ID # PMH/0915/01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date December 2019

Study information

Verified date June 2020
Source Premaitha Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sample
20 ml blood sample taken from vein in arm

Locations

Country Name City State
United Kingdom Premaitha Health Manchester

Sponsors (1)

Lead Sponsor Collaborator
Premaitha Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 months
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