Lead, Endocrine Disruption and Reproductive Outcomes - Tabular View

Tracking Information
First Received Date ^ICMJE	August 22, 2001
Last Updated Date	March 22, 2006
Start Date ^ICMJE	August 1996
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00023101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Lead, Endocrine Disruption and Reproductive Outcomes
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History, Longitudinal, Defined Population, Prospective Study
Condition ^ICMJE	Lead Poisoning Infertility
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	800
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years to 34 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00023101
Responsible Party
Study ID Numbers ^ICMJE	8337-CP-001
Study Sponsor ^ICMJE	National Institute of Environmental Health Sciences (NIEHS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Environmental Health Sciences (NIEHS)
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP