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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03590678




Registration number
NCT03590678
Ethics application status
Date submitted
4/05/2017
Date registered
18/07/2018
Date last updated
5/05/2022

Titles & IDs
Public title
Collection of Whole Blood Specimens in Pregnant Women
Scientific title
Prospective Collection of Whole Blood Specimens in Pregnant Women
Secondary ID [1] 0 0
RGH-015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Collect Whole Blood Specimens in Pregnant Women
Timepoint [1] 0 0
3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kuala Lumpur
Country [6] 0 0
Poland
State/province [6] 0 0
Silesia
Country [7] 0 0
Poland
State/province [7] 0 0
Piaseczno
Country [8] 0 0
Poland
State/province [8] 0 0
Warszawa
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok
Country [10] 0 0
Thailand
State/province [10] 0 0
Chiang Mai
Country [11] 0 0
Thailand
State/province [11] 0 0
Songkhla
Country [12] 0 0
Ukraine
State/province [12] 0 0
Kyiv
Country [13] 0 0
Ukraine
State/province [13] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Illumina, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03590678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kathryn Waldrep, MD
Address 0 0
Medical City Dallas Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03590678