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临床试验/NCT02677558
NCT02677558已完成不适用

The Impact of Obesity on Cardiac Function in Pregnancy

University of Cape Town1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Incidence of systolic and diastolic cardiac dysfunction in morbidly obese pregnant women compared to term pregnant women of normal weight through transthoracic echocardiography.

研究概览

简要总结

The purpose of this study is to determine the impact of obesity in pregnancy on maternal cardiac function. For this, morbidly obese term pregnant women (study group) and term pregnant women of normal weight are assessed by transthoracic echocardiography.

详细描述

INTRODUCTION:

The prevalence of obesity is increasing to alarming rates worldwide. The impact of obesity on cardiovascular health is well documented, but much less is known about the impact of obesity in pregnancy on maternal cardiac function. The aim of the current study is to investigate how the cardiovascular system of morbidly obese women adapts to the circulatory changes associated with pregnancy.

BACKGROUND:

Overweight and obesity is a major threat to global health. In 2013, 36.9% of all men and 38% of all women worldwide were overweight or obese as defined by a BMI of ≥25 kg/m2 or of ≥30 kg/m2 respectively. According to a systematic analysis for the Global Burden of Disease Study 2013, South Africa ranks third in a list of the world's most obese nations behind the United States and Mexico. The prevalence of overweight (BMI ≥25kg/m2) and obesity (BMI ≥30kg/m2) combined in the age group above 20 years is estimated to be 38.8% for men and 69.3% for women in South Africa. In the age group below 20 years, it is 18.8% for boys and 26.3% for girls. 42% of women above the age of 20 years and 9.6% of girls below 20 years are considered obese.

The impact of obesity on the structure and the function of the heart is well documented. Obesity is strongly associated with risk factors for the development of atherosclerotic disease such as hypertension, hyperlipidaemia, and diabetes. In addition, there is evidence that obesity in itself can lead to structural and functional changes in the heart. The following changes are commonly encountered in obesity:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI >/= 35kg/m2 for study group and </= 30kg/m2 for control group
  • uncomplicated singleton term pregnancy

排除标准

  • any comorbidities affecting cardiac function
  • receiving any cardiovascular drugs
  • in active labour
  • inability to give informed consent

结局指标

主要结局

Incidence of systolic and diastolic cardiac dysfunction in morbidly obese pregnant women compared to term pregnant women of normal weight through transthoracic echocardiography.

时间窗: At inclusion into study

次要结局

  • Correlation of degree of cardiac dysfunction in morbidly obese term pregnant women with BMI(At inclusion into study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Dyer

Professor

University of Cape Town

研究点 (1)

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