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

Down Syndrome Clinical Trial

— TWIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200041
• Other study ID #: PMH/0915/01
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2020
• Source: Premaitha Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Edward's Syndrome
• Patau Syndrome
• Syndrome

Intervention

Procedure:
• Blood sample
20 ml blood sample taken from vein in arm

Locations

Country	Name	City	State
United Kingdom	Premaitha Health	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Premaitha Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.	IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.	18 months