Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00971334
Eligibility Criteria:
Inclusion Criteria:
* Subject is female
* Subject is pregnant
* Subject is 18 years of age or older
* Subject provides a signed and dated informed consent
* Subject agrees to provide a 30-50mL blood sample
* Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
* Subject plans to undergo an amniocentesis and/or CVS procedure
* Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided
Exclusion Criteria:
* None
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00971334
Study Brief:
Protocol Section:
NCT00971334