- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023101
Lead, Endocrine Disruption and Reproductive Outcomes
March 22, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their husbands assesses endocrine dysfunction and adverse reproductive outcomes.
Residing in two study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers, have obtained permission to have a child, and have attempted to become pregnant over the course of the study.
Lead exposure is defined by lead levels in blood samples collected at the baseline survey (both women and their husbands), first and second trimesters, and at delivery (both maternal and cord blood).
Endocrine dysfunction is monitored by urinary hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG).
Reproductive endpoints include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery, and low birth weight.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
800
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
married women who:
- currently reside in two study areas in Shenyang, China
- between 20 and 34 years of age
- never smokers
- have obtained permission to have a child
- are attempting to become pregnant over the course of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1996
Study Registration Dates
First Submitted
August 22, 2001
First Submitted That Met QC Criteria
August 23, 2001
First Posted (Estimate)
August 24, 2001
Study Record Updates
Last Update Posted (Estimate)
March 23, 2006
Last Update Submitted That Met QC Criteria
March 22, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8337-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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