Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005405 |
| Other study ID # |
4322 |
| Secondary ID |
R03HL046168 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
January 19, 2016 |
| Start date |
September 1991 |
| Est. completion date |
September 1993 |
Study information
| Verified date |
January 2016 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and
measures of lipids in groups of women from the Hispanic Health and Nutrition Examination
Survey (Hispanic HANES) and the Framingham Heart Study.
Description:
BACKGROUND:
The relationships between parity or gravidity and measures of lipids in groups of women from
the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham
Heart Study offered insights into the health of an important minority group in the United
States and provided clues regarding hormonal mechanisms in lipoprotein metabolism.
DESIGN NARRATIVE:
In the Framingham cohort, the relationships among gravidity, LDL-cholesterol,
HDL-cholesterol and total cholesterol were prospectively studied. Each of these serum lipids
was tested as a potential mediator of associations between gravidity and various
cardiovascular endpoints. In the Hispanic HANES, the associations among parity, gravidity,
and lipid levels were examined in cross-sectional data on women of a different ethnic
background in whom birth rates tended to be high. Secondary analysis of these two datasets
was conducted, carefully considering aspects of the study designs. Bivariate analyses
generated mean lipid levels within parity or gravidity groups. HDL, LDL, and total
cholesterol were then stratified both by parity and other variables (such as age and smoking
status) so that interactions could be considered. Multivariate analyses were used to analyze
the effect of parity on lipids and cardiovascular disease events while controlling for a
variety of potentially confounding factors (such as body mass index, subscapular/triceps,
skinfold ratio, education, income, cigarette smoking, alcohol consumption, oral
contraceptive use, estrogen replacement therapy, menopausal status and type of menopause).
Interactions were also considered in multivariate models.
