Clinical trial NCT00241683: Fetal Growth Restriction & Maternal Cardiovascular Risk
Official title: Fetal Growth Restriction & Maternal Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-10-19
Enrollment: 704
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who were 4 to 12 years postpartum

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.

Eligibility 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

Primary outcomes:
measure: Blood pressure
timeFrame: 4 to 12 years after pregnancy
measure: Triglycerides and LDL cholesterol
timeFrame: 4 to 12 years after pregnancy
Secondary outcomes:
measure: Glucose
timeFrame: 4 to 12 years after pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Roberta B. Ness, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.