Fetal Growth Restriction & Maternal Cardiovascular Risk

NCT ID: NCT00241683

Last Updated: 2013-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Heart Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Roberta Ness, Dean, SPH

Dean - School of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberta B. Ness, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

References

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Catov JM, Dodge R, Yamal JM, Roberts JM, Piller LB, Ness RB. Prior preterm or small-for-gestational-age birth related to maternal metabolic syndrome. Obstet Gynecol. 2011 Feb;117(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e3182075626.

Reference Type RESULT
PMID: 21252733 (View on PubMed)

McClure CK, Bodnar LM, Ness R, Catov JM. Accuracy of maternal recall of gestational weight gain 4 to 12 years after delivery. Obesity (Silver Spring). 2011 May;19(5):1047-53. doi: 10.1038/oby.2010.300. Epub 2010 Dec 16.

Reference Type RESULT
PMID: 21164507 (View on PubMed)

McClure CK, Catov J, Ness R, Schwarz EB. Maternal visceral adiposity by consistency of lactation. Matern Child Health J. 2012 Feb;16(2):316-21. doi: 10.1007/s10995-011-0758-0.

Reference Type RESULT
PMID: 21404071 (View on PubMed)

Other Identifiers

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5R01HL076532-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1307

Identifier Type: -

Identifier Source: org_study_id

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