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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00359034
Eligibility Criteria:
Inclusion Criteria:
Study Group N:
Singleton pregnancy between 20 weeks 0 days and 36 weeks 0 days Normal obstetrical ultrasound in DAP at BCWH between 20-36 weeks GA
Study Group IUGR:
Singleton pregnancy between 20 weeks 0 days and 36 weeks 0 days Obstetrical ultrasound in DAP at BCWH between 20-36 weeks GA demonstrating IUGR (abdominal circumference AC \<10%) and one of: a)oligohydramnios (amniotic fluid index (AFI) \<5%) or b)abnormal umbilical artery (UA) Dopplers (absent or reversed end-diastolic flow)
Exclusion Criteria:
Study Group N:
Gestational age \<20 weeks or ≥36 weeks Multiple pregnancy Any known or suspected fetal structural anomaly (including cardiac) Chromosomal abnormalities (on amniocentesis or CVS) Abnormalities in fetal growth (AC \<10%; AC \>90%) Abnormalities in amniotic fluid volume (AFI \<5% or \>95%) Maternal hypertensive disorder (during or prior to pregnancy) Illicit drug use during pregnancy (cocaine, heroin, methamphetamine) Maternal medical history of any chronic illness requiring medication (eg lupus, asthma, etc.) Abnormal maternal serum triple screen (AFP ≥2.5MoM, hCG \>3.0 MoM)
Study Group IUGR:
Gestational age \<20 weeks or ≥36 weeks Multiple pregnancy Any known or suspected fetal structural anomaly (including cardiac) Chromosomal abnormalities (on amniocentesis or CVS) Normal fetal growth with AC ≥10% Illicit drug use during pregnancy (cocaine, heroin, methamphetamine)
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT00359034
Study Brief:
Protocol Section:
NCT00359034