NCT00043498

Brief Summary

A molecular epidemiologic study of African American and Hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
727

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

15.8 years

First QC Date

August 9, 2002

Last Update Submit

October 14, 2014

Conditions

Keywords

Pollutants

Outcome Measures

Primary Outcomes (2)

  • Neurobehavioral development

    1 to 12 years

  • Asthma

    2-12 years

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The present study enrolled 727 African American and Latino (Dominican) mothers and their children. The African American and Latino (Dominican) women were initially enrolled into the parent CCCEH study during pregnancy. Caucasian women are not included because a central purpose of the research is to evaluate health outcomes in a high risk, minority population.

Enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either African American or Dominican and who had resided in northern Manhattan or the South Bronx in New York City for at least 1 year before pregnancy. Women were excluded if they used illicit drugs, had diabetes, hypertension, or known HIV, or had their first prenatal visit after the 20th week of pregnancy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Columbia University, 722 W 168th St, 12th Floor

New York, New York, 10032, United States

Location

Related Publications (1)

  • Widen EM, Whyatt RM, Hoepner LA, Ramirez-Carvey J, Oberfield SE, Hassoun A, Perera FP, Gallagher D, Rundle AG. Excessive gestational weight gain is associated with long-term body fat and weight retention at 7 y postpartum in African American and Dominican mothers with underweight, normal, and overweight prepregnancy BMI. Am J Clin Nutr. 2015 Dec;102(6):1460-7. doi: 10.3945/ajcn.115.116939. Epub 2015 Oct 21.

Biospecimen

Retention: SAMPLES WITH DNA

We collected maternal urine during the third trimester of pregnancy, maternal blood at delivery, umbilical cord blood, meconium, blood and urine from the child at ages 24, 36, and 60 months.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Frederica P Perera, DrPH, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 12, 2002

Study Start

August 1, 1997

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations