Collection of Whole Blood Specimens in Pregnant Women

Completed

Conditions studied: Pregnancy Related

In brief

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.

Key facts

Study ID

NCT03590678

Run by

Illumina, Inc.

People needed

3000

Starts

2017-02-13

Expected to finish

2019-12-31

Last updated by the study team

2022-05-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Center for Fetal Medicine — Los Angeles, California, United States
• Maternal Fetal Medicine and Genetics — Riverside, California, United States
• Desert Perinatal Associates — Las Vegas, Nevada, United States
• Practice Research Organization — Dallas, Texas, United States
• Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine — Norfolk, Virginia, United States
• Mater Misericordiae Limited — South Brisbane, Queensland, Australia
• Kuala Lumpur Hospital — Kuala Lumpur, Malaysia
• Centrum Medyczne Angelius Provita — Katowice, Silesian Voivodeship, Poland
• CENTRUM INNOWACYJNYCH TERAPII Sp. z — Piaseczno, Poland
• FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA — Warsaw, Poland
• Phramongkutklao Hospital — Bangkok, Thailand
• Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
• Songklanagarind Hospital — Songkhla, Thailand
• "Institute of general practice - family medicine" — Kyiv, Ukraine
• LLC "Reproductive Genetics Clinic "Victoria" — Kyiv, Ukraine
• Medical Center "Pulse", Small Private Business — Vinnytsia, Ukraine

Full record on ClinicalTrials.gov

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