NCT00015613

Brief Summary

The most persistent and intractable cause of infant and child mortality and morbidity in the US remains preterm and low birthweight deliveries. Pregnant women in the United States experience the highest incidence of these complications among developed countries. Even more disturbing is the observation that immigrant Hispanic women experience worsening birth outcomes the longer they live here, despite increasing access to prenatal care, improved socio-economic status and better education. The purpose of this study is to identify the potential acculturation-related risk factors for preterm and low birthweight (PTLBW) delivery among Hispanic women of varying lengths of US residency. It is hypothesized that changes in factors associated with acculturation, such as poor nutritional intake, job stress and occupational exposures to pesticides or other hazards, and certain types of genital infections, can best explain the worsening of pregnancy outcomes among Hispanic immigrant women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1998

Typical duration for all trials

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, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2001

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

November 3, 2005

Status Verified

September 1, 2002

First QC Date

April 23, 2001

Last Update Submit

November 2, 2005

Conditions

Infant, Low Birth WeightInfant, Premature, Diseases

Keywords

HispanicsAcculturationMaternal ExposureInfant, Low Birth WeightInfant, PrematureOrganophosphatesPesticidesStressNutrition

Eligibility Criteria

Age12 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Pregnant Hispanic women receiving prenatal care services at San Joaquin General Hospital's Healthy Beginnings Clinics in Stockton California

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

Sponsors & Collaborators

MeSH Terms

Conditions

Infant, Premature, DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Marc B Schenker, MD, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Julia Walsh, MD, DTPH

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 23, 2001

First Posted

April 25, 2001

Study Start

August 1, 1998

Study Completion

September 1, 2001

Last Updated

November 3, 2005

Record last verified: 2002-09