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OpenTrials
Completed

NCT Number: NCT03590678

Collection of Whole Blood Specimens in Pregnant Women

To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.

Completed

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mater Misericordiae Limited, South Brisbane, Queensland, Australia

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About this study

This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.

After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be 18 years of age or older at enrollment,
  • Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
  • Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling [cordocentesis]) for cytogenetic analysis of the fetus

Exclusion criteria

  • Has a known maternal chromosomal anomaly,
  • Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
  • Has a history of transplant or malignancy, or
  • Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
  • Already participated in this study (enrolled previously).

Treatment and study plan

Primary outcomes

  1. Collect Whole Blood Specimens in Pregnant Women

    Time frame: 3 years

    To collect maternal whole blood specimens from approximately 5,150 women with corresponding cytogenetic results from invasive prenatal diagnostic procedures (performed per the standard of care) to achieve sample size goals

Sponsors and collaborators

Lead sponsor

Illumina, Inc.

Industry

Registry information

Official study title

Prospective Collection of Whole Blood Specimens in Pregnant Women

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
May 5, 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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