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

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Patau Syndrome; Edward's Syndrome
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M15 6SZ
    • Premaitha Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Low Risk; 350 Low risk The only intervention is a 20 ml blood sample will be taken from each participant.	Procedure: Blood sample; 20 ml blood sample taken from vein in arm
OTHER: 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.	Procedure: Blood sample; 20 ml blood sample taken from vein in arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Premaitha Health
• Investigators: Principal Investigator: Asma Khalil, MBBS, National Health Service, United Kingdom

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (ACTUAL): June 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Heart Defects, Congenital; Cardiovascular Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome
• Other Study ID Numbers: PMH/0915/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IONA Test results being given to patients