Infant, Low Birth WeightNCT00015613
Farm Work & Preterm Low Birthweight Among Hispanic Women
An observational study of Infant, Low Birth Weight and Infant, Premature, Diseases, run by National Institute of Environmental Health Sciences (NIEHS).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant, Low Birth Weight, Infant, Premature, Diseases
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to Sep 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Pregnant Hispanic women receiving prenatal care services at San Joaquin General Hospital's Healthy Beginnings Clinics in Stockton California
About this study
Official title: Study of Hispanic Acculturation Reproduction and the Environment (SHARE)
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.
Read the detailed description
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 US experience the highest incidence of these complications among developed countries. Despite many efforts at increasing prenatal care, rates of preterm delivery have not substantially changed in the last decade. Even more disturbing is the observation that immigrant Hispanic women experience worsening birth outcomes the longer they live in the US, despite increasing access to prenatal care, improved socio-economic status and better education. (Within five years after moving to the US, the odds ratio for preterm low birth weight delivery increases by 1.9, from 4% to 7%.)
As migrant women become acculturated to the US, they must be exposed to factors that adversely affect pregnancy outcomes. But the known risk factors, such as poverty, lack of education, smoking, substance abuse, inadequate pregnancy weight gain, low pre-pregnancy weight, high altitude, chronic diseases, primipara, and high parity, explain only a small percentage of this change in incidence.
The prospective study will enroll a cohort of approximately 1500 pregnant Hispanic women attending prenatal care services through an OB/GYN group at the San Joaquin General Hospital in Stockton, CA. The majority of Hispanic women (67%) receiving prenatal care through this group are Mexican immigrants of varying lengths of US residency, and up to 26% of them are involved in farm labor and/or other types of manual labor. Eighteen percent are US-born Mexican women. A study of this unique population of Hispanic women of varying lengths of US residency, and factors related to occupational risks, acculturation and preterm low birth weight deliveries, will provide an excellent opportunity to examine the factors of acculturation-based causes of preterm low birthweight (PTLBW).
The investigators hypothesize that job stress and occupational exposures related to farm work can best explain the worsening of pregnancy outcomes among Hispanic women. However, in order to ensure an understanding of the mechanism of this increased rate of preterm low birthweight within this population, this study will also examine other risk factors that could possibly be associated with acculturation and preterm low birthweight. Such factors include changes in nutrition intake, and certain types of genital infections such as Bacterial Vaginosis, Gonorrhea and Chlamydia.
The knowledge that emerges will have direct application for designing improved programs for the prevention of preterm low birthweight deliveries among Hispanic women. Just as important, it will provide insight into the underlying causes of the scandalously high rates throughout all US populations.
- Keywords
- Hispanics, Acculturation, Maternal Exposure, Infant, Low Birth Weight, Infant, Premature, Organophosphates, Pesticides, Stress, Nutrition
- Medical subject headings
- Infant, Premature, Diseases, Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2001 (estimated)
- Study startAug 1998
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Marc B Schenker, MD, MPH, Principal investigator, University of California, DavisJulia Walsh, MD, DTPH, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015613
- Sponsor's protocol ID
- 9867-CP-001
- Status last verified
- Sep 2002
- First submitted
- 23 Apr 2001
- Last updated
- 3 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hispanic Acculturation Reproduction and the Environment (SHARE)
- ClinicalTrials.gov ID
- NCT00015613
- Acronym / sponsor ID
- 9867-CP-001
- Keywords
- Hispanics, Acculturation, Maternal Exposure, Infant, Low Birth Weight, Infant, Premature, Organophosphates, Pesticides, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Aug 1998
- Study completion
- Sep 2001
- First posted
- 25 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 US experience the highest incidence of these complications among developed countries. Despite many efforts at increasing prenatal care, rates of preterm delivery have not substantially changed in the last decade. Even more disturbing is the observation that immigrant Hispanic women experience worsening birth outcomes the longer they live in the US, despite increasing access to prenatal care, improved socio-economic status and better education. (Within five years after moving to the US, the odds ratio for preterm low birth weight delivery increases by 1.9, from 4% to 7%.)
As migrant women become acculturated to the US, they must be exposed to factors that adversely affect pregnancy outcomes. But the known risk factors, such as poverty, lack of education, smoking, substance abuse, inadequate pregnancy weight gain, low pre-pregnancy weight, high altitude, chronic diseases, primipara, and high parity, explain only a small percentage of this change in incidence.
The prospective study will enroll a cohort of approximately 1500 pregnant Hispanic women attending prenatal care services through an OB/GYN group at the San Joaquin General Hospital in Stockton, CA. The majority of Hispanic women (67%) receiving prenatal care through this group are Mexican immigrants of varying lengths of US residency, and up to 26% of them are involved in farm labor and/or other types of manual labor. Eighteen percent are US-born Mexican women. A study of this unique population of Hispanic women of varying lengths of US residency, and factors related to occupational risks, acculturation and preterm low birth weight deliveries, will provide an excellent opportunity to examine the factors of acculturation-based causes of preterm low birthweight (PTLBW).
The investigators hypothesize that job stress and occupational exposures related to farm work can best explain the worsening of pregnancy outcomes among Hispanic women. However, in order to ensure an understanding of the mechanism of this increased rate of preterm low birthweight within this population, this study will also examine other risk factors that could possibly be associated with acculturation and preterm low birthweight. Such factors include changes in nutrition intake, and certain types of genital infections such as Bacterial Vaginosis, Gonorrhea and Chlamydia.
The knowledge that emerges will have direct application for designing improved programs for the prevention of preterm low birthweight deliveries among Hispanic women. Just as important, it will provide insight into the underlying causes of the scandalously high rates throughout all US populations.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc B Schenker, MD, MPH principal investigator
University of California, Davis
Julia Walsh, MD, DTPH principal investigator
University of California, Berkeley
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Low Birth Weight and Infant, Premature, Diseases, run by National Institute of Environmental Health Sciences (NIEHS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2005.