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

NCT03200041 | Completed

• 1 other identifier: PMH/0915/01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Patau Syndrome; Edward's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low Risk

OTHER

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

Procedure: Blood sample

High Risk

OTHER

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

Interventions

Blood sample PROCEDURE

20 ml blood sample taken from vein in arm

High Risk; Low Risk

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant herself has down syndrome or other chromosomal abnormality

Sponsors & Collaborators

• Premaitha Health: lead

Study Sites (1)

Premaitha Health

Manchester, M15 6SZ, United Kingdom

Location

MeSH Terms

Conditions

Down Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Asma Khalil, MBBS

  National Health Service, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 27, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)