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:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01663350
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older at enrollment
* Clinically confirmed pregnancy
* Gestational age ≥8 weeks, 0 days
* Planned or completed prenatal serum screening\* (drawn during 1st and/or 2nd trimester)
* Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)
* Able to provide consent for participation using language appropriate forms
Exclusion Criteria:
* Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
* Prenatal screening determination by Nuchal Translucency (NT) measurement only
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01663350
Study Brief:
Protocol Section:
NCT01663350