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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Down Syndrome Patau Syndrome Edward's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Low Risk

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

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

20 ml blood sample taken from vein in arm

High Risk

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

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

20 ml blood sample taken from vein in arm

Interventions

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Blood sample

20 ml blood sample taken from vein in arm

Intervention Type PROCEDURE

Eligibility Criteria

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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.