NCT03200041

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Premaitha Health · Industry
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Down Syndrome
• Patau Syndrome
• Edward's Syndrome

Interventions

Type	Name	Description
PROCEDURE	Blood sample	20 ml blood sample taken from vein in arm

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-06-27
• Last updated: 2020-06-11

Locations

1 site across 1 country: United Kingdom