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

Not Applicable

Completed

• Conditions: Down Syndrome; Patau Syndrome; Edward's Syndrome
• Interventions: Procedure: Blood sample

• Registration Number: NCT03200041
• Lead Sponsor: Premaitha Health

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-27
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Risk	Blood sample	150 High Risk going onto invasive diagnostic procedure. The only intervention is a 20 ml blood sample will be taken from each participant.
Low Risk	Blood sample	350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.

Primary Outcome Measures

Name	Time	Method
Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.	18 months	IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.

Trial Locations

Locations (1)

Premaitha Health; 🇬🇧 Manchester, United Kingdom