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Collection of Whole Blood Specimens in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590678
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Illumina, Inc.

Study Description
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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.

Condition or disease
Pregnancy Related

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.

Study Design
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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Whole Blood Specimens in Pregnant Women
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : December 31, 2019
Groups and Cohorts
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Group/Cohort
1
Subject is scheduled for an invasive procedure and did not have NIPT testing in current pregnancy
2
Subject is scheduled for an invasive procedure and has a known positive or no-call result from a targeted NIPT in the current pregnancy


Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Human blood specimens will be spun to plasma and stored at -80C freezers

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with a viable pregnancy of at least 10 weeks, 0 days gestation who are scheduled for an invasive procedure performed per the standard of care.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590678


Locations
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United States, California
Center for Fetal Medicine
Los Angeles, California, United States, 90048
Maternal Fetal Medicine and Genetics
Riverside, California, United States, 92506
United States, Nevada
Desert Perinatal Associates
Las Vegas, Nevada, United States, 89148
United States, Texas
Practice Research Organization
Dallas, Texas, United States, 75230
United States, Virginia
Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine
Norfolk, Virginia, United States, 23507
Malaysia
Kuala Lumpur Hospital
Kuala Lumpur, Malaysia
Poland
Centrum Medyczne Angelius Provita
Katowice, Silesia, Poland, 40-611
CENTRUM INNOWACYJNYCH TERAPII Sp. z
Piaseczno, Poland, 05-500
FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA
Warszawa, Poland, 00-172
Thailand
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Songklanagarind Hospital
Songkhla, Thailand, 90110
Ukraine
"Institute of general practice - family medicine"
Kyiv, Ukraine, 02132
LLC "Reproductive Genetics Clinic "Victoria"
Kyiv, Ukraine, 04070
Medical Center "Pulse", Small Private Business
Vinnytsya, Ukraine, 21001
Sponsors and Collaborators
Illumina, Inc.
Investigators
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Principal Investigator: Kathryn Waldrep, MD Medical City Dallas Hospital
More Information
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Responsible Party: Illumina, Inc.
ClinicalTrials.gov Identifier: NCT03590678    
Other Study ID Numbers: RGH-015
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No