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OpenTrials
Completed

NCT Number: NCT03200041

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Edward's Syndrome Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Patau Syndrome Trisomy 13 Syndrome Trisomy 18 Syndrome

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Premaitha Health

Manchester, M15 6SZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

20 ml blood sample taken from vein in arm

Primary outcomes

  1. Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.

    Time frame: 18 months

    IONA test results will be compared to Karyotyping from birth outcome and invasive procedures.

Sponsors and collaborators

Lead sponsor

Premaitha Health

Industry

Registry information

Acronym: TWIN

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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