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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03590678