Lead, Endocrine Disruption and Reproductive Outcomes

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00023101
First received: August 22, 2001
Last updated: March 22, 2006
Last verified: March 2006

August 22, 2001
March 22, 2006
August 1996
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Complete list of historical versions of study NCT00023101 on ClinicalTrials.gov Archive Site
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Lead, Endocrine Disruption and Reproductive Outcomes
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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.

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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Lead Poisoning
  • Infertility
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
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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.
Both
20 Years to 34 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00023101
8337-CP-001
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National Institute of Environmental Health Sciences (NIEHS)
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National Institute of Environmental Health Sciences (NIEHS)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP