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Fetal Growth Restriction & Maternal Cardiovascular Risk

This study is ongoing, but not recruiting participants.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00241683
  Purpose

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


Condition
Cardiovascular Diseases
Heart Diseases

MedlinePlus related topics:   Heart Disease in Women    Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Defined Population

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   August 2005
Estimated Study Completion Date:   July 2010

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:

The cohort study will test whether exposed women, with a previous intrauterine growth restriction (IUGR) baby, versus unexposed women, with a pregnancy not complicated by IUGR, will have elevations in markers of cardiovascular risk. Exposure will be 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 will have had a singleton in the > 20%tile. Five to nine years postpartum, women will be 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 will consist of ANOVA and ANCOVA analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241683

Sponsors and Collaborators

Investigators
Investigator:     Roberta Ness     University of Pittsburgh    
  More Information


Study ID Numbers:   1307
First Received:   October 17, 2005
Last Updated:   October 17, 2005
ClinicalTrials.gov Identifier:   NCT00241683
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Fetal Growth Retardation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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