Pregnancy Clinical Trial
Official title:
Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS
The goal of this study is to examine the effects of in utero and postnatal exposure to environmental pollutants in a cohort of pregnant women and their newborns in Krakow, Poland
Status | Completed |
Enrollment | 505 |
Est. completion date | January 2006 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion criteria: - Pregnant women between 18 and 40 years old - Resided for at least 1 year within proximity to air monitoring station Exclusion criteria: - Smoking/ illicit drugs - Hypertension - Diabetes - Occupational exposure |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Columbia University, 722 W 168th St, 12th Floor | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fetal growth | Fetal growth is assessed at birth by weight, length, head circumference, and size for gestational age | Birth | No |
Secondary | Childhood growth and neurodevelopmental outcomes | At 6 months of age, information regarding physical growth was collected from pediatric assessment and neurobehavioral development was evaluated using the Fagan Test of Infant Intelligence. At one year of age and annual time intervals thereafter, physical growth was assessed during a pediatric examination and neurobehavioral development was assessed with the Bayley Scales of Infant Development. | 3 months - 3 years | No |
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