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OpenTrials
Completed

NCT Number: NCT00241683

Fetal Growth Restriction & Maternal Cardiovascular Risk

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.

Completed

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Key information

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood pressure

    Time frame: 4 to 12 years after pregnancy

  2. Triglycerides and LDL cholesterol

    Time frame: 4 to 12 years after pregnancy

Secondary outcomes

  1. Glucose

    Time frame: 4 to 12 years after pregnancy

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2005
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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