Lead Mobilization & Bone Turnover in Pregnancy/Lactation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00011726

Enrollment

1000

Registered

2001-03-01

Start date

1996-08-31

Completion date

2002-12-31

Last updated

2006-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lead Poisoning

Keywords

Pregnancy, Lead Exposure, Lactation, Bone Mineralization, Maternal-Fetal Exchange

Brief summary

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.

Interventions

None listed

Study design

Observational model

NATURAL_HISTORY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Outcome results