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OpenTrials
Completed

NCT Number: NCT04488393

Clinical Performance of NIPT in Multiple Gestation Pregnancies

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Completed

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Key information

Conditions

Trisomy 21 in Fetus

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

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

Inclusion criteria

  • subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
  • subject was 18 or older at the time of NIPT

Exclusion criteria

  • none

Treatment and study plan

MaterniT21 PLUS and GENOME Laboratory-Developed Tests

Device

Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.

Primary outcomes

  1. Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.

    Time frame: time from maternal blood draw to delivery

  2. Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.

    Time frame: time from maternal blood draw to delivery

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Sequenom, Inc/Laboratory Corporation of America Holdings

Registry information

Official study title

Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Dec 7, 2022

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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