NCT00023101

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2001

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

August 22, 2001

Last Update Submit

March 22, 2006

Conditions

Lead PoisoningInfertility

Keywords

leadendocrine dysfunction

Eligibility Criteria

Age20 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lead PoisoningInfertility

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersGenital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2001

First Posted

August 24, 2001

Study Start

August 1, 1996

Last Updated

March 23, 2006

Record last verified: 2006-03