Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023101
Status:
COMPLETED
Last Update Posted:
2006-03-23
First Post:
2001-08-22
Brief Title:
Lead Endocrine Disruption and Reproductive Outcomes
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None