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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590678
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Observational
Estimated Enrollment : 5150 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
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2019

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



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


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).

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


Contacts
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Contact: Linda Leety (239) 565-3712 lleety@illumina.com
Contact: Jocelyn Sinclair jsinclair@illumina.com

Locations
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United States, California
Center for Fetal Medicine Recruiting
Los Angeles, California, United States, 90048
Contact: Lawrence D Platt, MD    323-857-1952    ldplatt@gmail.com   
Principal Investigator: Lawrence D Platt, MD         
Maternal Fetal Medicine and Genetics Recruiting
Riverside, California, United States, 92506
Contact: Stephanie Gutierrez    951-683-4675    stephanie.gutierrez.gasca@gmail.com   
Principal Investigator: Herb Brar, MD         
United States, Nevada
Desert Perinatal Associates Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Rebecca Lynn McCoy    702-341-6610    rmccoy@dpanv.com   
Principal Investigator: Joseph Adashek, MD         
United States, Texas
Practice Research Organization Recruiting
Dallas, Texas, United States, 75230
Contact: Kathryn Yates    972-566-4660    kyates@practiceresearch.net   
Principal Investigator: Kathryn Waldrep, MD         
United States, Virginia
Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine Recruiting
Norfolk, Virginia, United States, 23507
Contact: Rachel J Gräbe    757-446-0579    graberj@evms.edu   
Principal Investigator: Steven L Warsof, MD         
Malaysia
Kuala Lumpur Hospital Not yet recruiting
Kuala Lumpur, Malaysia
Contact: Noor H. Yussoff, MD    013363585    aznky@yahoo.com   
Principal Investigator: Noor H. Yussoff, MD         
Poland
Centrum Medyczne Angelius Provita Not yet recruiting
Katowice, Silesia, Poland, 40-611
Contact: Marivsa Kiecka, PhD    48327837305    m.kiecka@angelius.org   
Contact: Ewa Gwiazda    48327837307    e.gwiazda@angelius.org   
Principal Investigator: Marivsa Kiecka, PhD         
Sub-Investigator: Grzegorz Mańka, PhD         
CENTRUM INNOWACYJNYCH TERAPII Sp. z Not yet recruiting
Piaseczno, Poland, 05-500
Contact: Rafal Szurnicki    22 290 53 50    rafal.szurnicki@citrials.pl   
Contact: Anna Tomaszewska-Bielecka, RN    22 290 53 50    anna.tomaszewska@citrials.pl   
Principal Investigator: Adam Muszyński, MD         
FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA Not yet recruiting
Warszawa, Poland, 00-172
Contact: Joanna Pulkowska    +48226161387    tomcior1@gmail.com   
Contact: Anna Kucinska-Chahwan, MD    +48226161387    ankakucinska@wp.pl   
Principal Investigator: Tomasz Roszkowski, MD         
Thailand
Phramongkutklao Hospital Not yet recruiting
Bangkok, Thailand, 10400
Contact: Nutthaphon Imsom-Somboon, MD    66 2 354 7690    nutthaphon114@hotmail.com   
Principal Investigator: Nutthaphon Imsom-Somboon, MD         
Maharaj Nakorn Chiang Mai Hospital Not yet recruiting
Chiang Mai, Thailand, 50200
Contact: Wanapirak Chanane    66 53 945 552    cwanapir@gmail.com   
Songklanagarind Hospital Not yet recruiting
Songkhla, Thailand, 90110
Contact: Ninlapa Pruksanusak    66 74 451 245    nin056@hotmail.com   
Ukraine
"Institute of general practice - family medicine" Not yet recruiting
Kyiv, Ukraine, 02132
Contact: Nataliya Vladykina, MD    +38 (044) 220 36 03    Vladykina.ivf@gmail.com   
Principal Investigator: Nataliya Vladykina, MD         
LLC "Reproductive Genetics Clinic "Victoria" Not yet recruiting
Kyiv, Ukraine, 04070
Contact: Victoria Badiuk, PhD    +38 (044) 425 51 66    vbadiuk@ukr.net   
Principal Investigator: Lilia Davyd, MD         
Medical Center "Pulse", Small Private Business Not yet recruiting
Vinnytsya, Ukraine, 21001
Contact: Sidorov Andrii, MD    +380 (432) 61 26 96    dr.sidorov@mail.ru   
Principal Investigator: Oksana Taran, MD PhD         
Sponsors and Collaborators
Illumina, Inc.
Investigators
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Principal Investigator: Kathryn Waldrep, MD Medical City Dallas Hospital

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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: July 18, 2018
Last Verified: July 2018
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