Fetal Growth Restriction & Maternal Cardiovascular Risk

Cardiovascular Diseases Clinical Trial

Official title:

Fetal Growth Restriction & Maternal Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241683
• Other study ID #: 1307
• Secondary ID: 5R01HL076532-03
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: January 18, 2013
• Start date: August 2005
• Est. completion date: April 2009

Study information

• Verified date: January 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Fetal Growth Retardation
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

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):225-32. doi: 10.1097/AOG.0b013e3182075626. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		4 to 12 years after pregnancy	No
Primary	Triglycerides and LDL cholesterol		4 to 12 years after pregnancy	No
Secondary	Glucose		4 to 12 years after pregnancy	No