Collection of Whole Blood Specimens in Pregnant Women

Prospective Collection of Whole Blood Specimens in Pregnant Women

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03590678

Enrollment

3000

Registered

2018-07-18

Start date

2017-02-13

Completion date

2019-12-31

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

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

Outcome results