Fetal Growth Restriction & Maternal Cardiovascular Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roberta Ness, Dean, SPH, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00241683
First received: October 17, 2005
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition
Cardiovascular Diseases
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fetal Growth Restriction & Maternal Cardiovascular Risk

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 4 to 12 years after pregnancy ] [ Designated as safety issue: No ]
  • Triglycerides and LDL cholesterol [ Time Frame: 4 to 12 years after pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose [ Time Frame: 4 to 12 years after pregnancy ] [ Designated as safety issue: No ]

Enrollment: 704
Study Start Date: August 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who were 4 to 12 years postpartum

Criteria

Inclusion criteria:

  • women 4 to 12 years after delivery of singleton infant
  • women who gave birth between 1997 and 2002 at Magee-Womens Hospital in Pittsburgh, Pennsylvania

Exclusion criteria:

  • women who had preeclampsia
  • women who had prepregnancy hypertension
  • women who had diabetes
  • women who were currently pregnant or reported a prepregnancy chronic condition
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00241683

Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Roberta B. Ness, MD, MPH The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Roberta Ness, Dean, SPH, Dean - School of Public Health, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00241683     History of Changes
Other Study ID Numbers: 1307, 5R01HL076532-03
Study First Received: October 17, 2005
Last Updated: January 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Fetal Growth Retardation
Heart Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014