Collection of Whole Blood Specimens in Pregnant Women

Pregnancy Related Clinical Trial

Official title:

Prospective Collection of Whole Blood Specimens in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590678
• Other study ID #: RGH-015
• Status: Completed
• Start date: February 13, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2022
• Source: Illumina, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy Related

Locations

Country	Name	City	State
Australia	Mater Misericordiae Limited	South Brisbane	Queensland
Malaysia	Kuala Lumpur Hospital	Kuala Lumpur
Poland	Centrum Medyczne Angelius Provita	Katowice	Silesia
Poland	CENTRUM INNOWACYJNYCH TERAPII Sp. z	Piaseczno
Poland	FERTINA Sp. z o.o. SPÓLKA KOMANDYTOWA	Warszawa
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Songklanagarind Hospital	Songkhla
Ukraine	"Institute of general practice - family medicine"	Kyiv
Ukraine	LLC "Reproductive Genetics Clinic "Victoria"	Kyiv
Ukraine	Medical Center "Pulse", Small Private Business	Vinnytsya
United States	Practice Research Organization	Dallas	Texas
United States	Desert Perinatal Associates	Las Vegas	Nevada
United States	Center for Fetal Medicine	Los Angeles	California
United States	Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine	Norfolk	Virginia
United States	Maternal Fetal Medicine and Genetics	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Illumina, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Malaysia,  Poland,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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