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OpenTrials
Completed

NCT Number: NCT00023101

Lead, Endocrine Disruption and Reproductive Outcomes

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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Key information

Age range

20 year–34 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS)

Nih

Registry information

Important dates

Study start
1996
First posted
Aug 24, 2001
Registry last updated
Mar 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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