Collection of Whole Blood Specimens in Pregnant Women
- Conditions
- Pregnancy Related
- Registration Number
- NCT03590678
- Lead Sponsor
- Illumina, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3000
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collect Whole Blood Specimens in Pregnant Women 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
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, Silesia, Poland
CENTRUM INNOWACYJNYCH TERAPII Sp. z
🇵🇱Piaseczno, Poland
FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA
🇵🇱Warszawa, Poland
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