Collection of Whole Blood Specimens in Pregnant Women

Completed

• 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.

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-18
• Primary Completion: 2019-08-30
• Study Completion: 2019-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3000

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 & 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

Trial Locations

Locations (16)

Mater Misericordiae Limited; 🇦🇺 South Brisbane, Queensland, Australia

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Chiang Mai, Thailand

FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA; 🇵🇱 Warszawa, Poland

CENTRUM INNOWACYJNYCH TERAPII Sp. z; 🇵🇱 Piaseczno, Poland

Songklanagarind Hospital; 🇹🇭 Songkhla, Thailand

Center for Fetal Medicine; 🇺🇸 Los Angeles, California, United States

Maternal Fetal Medicine and Genetics; 🇺🇸 Riverside, California, United States

Practice Research Organization; 🇺🇸 Dallas, Texas, United States

Kuala Lumpur Hospital; 🇲🇾 Kuala Lumpur, Malaysia

Centrum Medyczne Angelius Provita; 🇵🇱 Katowice, Silesia, Poland

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

"Institute of general practice - family medicine"; 🇺🇦 Kyiv, Ukraine

Medical Center "Pulse", Small Private Business; 🇺🇦 Vinnytsya, Ukraine

LLC "Reproductive Genetics Clinic "Victoria"; 🇺🇦 Kyiv, Ukraine

Desert Perinatal Associates; 🇺🇸 Las Vegas, Nevada, United States

Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine; 🇺🇸 Norfolk, Virginia, United States