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

Premaitha Health

Status: Completed

Conditions: Patau Syndrome; Edward's Syndrome; Down Syndrome

Treatments: Procedure: Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT03200041

PMH/0915/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Low Risk

Other group

Description:

350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.

Treatment:

Procedure: Blood sample

High Risk

Other group

Description:

150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant.

Treatment:

Procedure: Blood sample