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Clinical Trials/NCT00241683
NCT00241683
Completed
Not Applicable

Fetal Growth Restriction & Maternal Cardiovascular Risk

The University of Texas Health Science Center, Houston0 sites704 target enrollmentAugust 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
704
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

To determine whether or not women with a history of having a baby with intrauterine growth retardation (IUGR) was more likely to have risk factors for cardiovascular disease versus women with a pregnancy not complicated by IUGR.

Detailed Description

BACKGROUND: Intrauterine growth restriction leads to major neonatal morbidity and mortality. Moreover, recent birth registry studies have suggested that women bearing IUGR babies may have an elevated risk of cardiovascular disease. DESIGN NARRATIVE: This cohort study tested whether exposed women, with a previous intrauterine growth restriction (IUGR) baby, versus unexposed women, with a pregnancy not complicated by IUGR, had elevations in markers of cardiovascular risk. Exposure was defined among a geographically defined cohort as having had a singleton baby in the \< 5 %tile of weight for gestational age, in the absence of pre-pregnancy diabetes., hypertension, renal disease, or hypertension in pregnancy; controls had a singleton in the \> 20%tile. Four to twelve years postpartum, women were assessed for multiple markers of cardiovascular risk, including blood pressure, lipids, adiposity, glucose and insulin, homocysteine and folate, markers of inflammation, markers of endothelial function, markers of angiogenesis, and markers of vascular function. Data analysis consisted of ANOVA and ANCOVA analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
April 2009
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberta Ness, Dean, SPH

Dean - School of Public Health

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood pressure

Time Frame: 4 to 12 years after pregnancy

Triglycerides and LDL cholesterol

Time Frame: 4 to 12 years after pregnancy

Secondary Outcomes

  • Glucose(4 to 12 years after pregnancy)

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