Clinical trial NCT03590678: Collection of Whole Blood Specimens in Pregnant Women
Official title: Prospective Collection of Whole Blood Specimens in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a viable pregnancy of at least 10 weeks, 0 days gestation who are scheduled for an invasive procedure performed per the standard of care.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Collect Whole Blood Specimens in Pregnant Women
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Fetal Medicine
state: California
city: Riverside
country: United States
facility: Maternal Fetal Medicine and Genetics
state: California
city: Las Vegas
country: United States
facility: Desert Perinatal Associates
state: Nevada
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: Norfolk
country: United States
facility: Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine
state: Virginia
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Kuala Lumpur
country: Malaysia
facility: Kuala Lumpur Hospital
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Silesia
city: Piaseczno
country: Poland
facility: CENTRUM INNOWACYJNYCH TERAPII Sp. z
city: Warszawa
country: Poland
facility: FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Kyiv
country: Ukraine
facility: "Institute of general practice - family medicine"
city: Kyiv
country: Ukraine
facility: LLC "Reproductive Genetics Clinic "Victoria"
city: Vinnytsya
country: Ukraine
facility: Medical Center "Pulse", Small Private Business
Study officials:
affiliation: Medical City Dallas Hospital
name: Kathryn Waldrep, MD
role: PRINCIPAL_INVESTIGATOR
References: