Lead Mobilization & Bone Turnover in Pregnancy/Lactation

We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk). A cohort, ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  1. Positive pregnancy test, age 12-35 and informed consent;
  2. Gestation <28 weeks at entry to prenatal care;
  3. No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
  4. Not corticosteroid user or diagnosed use of illicit drugs;
  5. Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Natural History
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1996

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

February 27, 2001

First Submitted That Met QC Criteria

February 28, 2001

First Posted (Estimate)

March 1, 2001

Study Record Updates

Last Update Posted (Estimate)

March 23, 2006

Last Update Submitted That Met QC Criteria

March 22, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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