Collection of Whole Blood Specimens in Pregnant Women

Prospective 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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited
• Malaysia
  • Kuala Lumpur, Malaysia
    • Kuala Lumpur Hospital
• Poland
  • Piaseczno, Poland, 05-500
    • CENTRUM INNOWACYJNYCH TERAPII Sp. z
  • Warszawa, Poland, 00-172
    • FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA
  • Silesia
    • Katowice, Silesia, Poland, 40-611
      • Centrum Medyczne Angelius Provita
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind hospital
• Ukraine
  • Kyiv, Ukraine, 02132
    • "Institute of general practice - family medicine"
  • Kyiv, Ukraine, 04070
    • LLC "Reproductive Genetics Clinic "Victoria"
  • Vinnytsya, Ukraine, 21001
    • Medical Center "Pulse", Small Private Business
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Center for Fetal Medicine
    • Riverside, California, United States, 92506
      • Maternal Fetal Medicine and Genetics
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Desert Perinatal Associates
  • Texas
    • Dallas, Texas, United States, 75230
      • Practice Research Organization
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect Whole Blood Specimens in Pregnant Women	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	3 years

Collaborators and Investigators

• Sponsor: Illumina, Inc.
• Investigators: Principal Investigator: Kathryn Waldrep, MD, Medical City Dallas Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RGH-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No