CompletedNot Applicable

Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies

United Kingdom1,000 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range16 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.

Timeframe: 18 months

Trial details

NCT IDNCT03200041

SponsorPremaitha Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12

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