Diastolic Dysfunction in the Pregnant Woman With Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women
研究概览
简要总结
This is a prospective observational study conducted at the Maternity and Neonatology Center of Tunis to evaluate cardiac diastolic function in women with preeclampsia compared with normotensive pregnant women. A total of 80 pregnant women in the third trimester were enrolled, including 40 with preeclampsia (mostly severe forms) and 40 healthy controls. All participants underwent standardized transthoracic echocardiography to assess left ventricular diastolic function according to the 2016 ASE/EACVI recommendations.
详细描述
Preeclampsia is a major hypertensive disorder of pregnancy associated with increased maternal morbidity and mortality, as well as long-term cardiovascular risk. Cardiac remodeling in this context is characterized by increased vascular stiffness and concentric left ventricular hypertrophy, which may lead to subclinical diastolic dysfunction despite preserved systolic function.
This prospective observational study was designed to evaluate left ventricular diastolic function in women with preeclampsia compared to normotensive pregnant women. Eighty participants in the third trimester of pregnancy were included: 40 diagnosed with preeclampsia (mainly severe forms) and 40 normotensive controls. Women with pre-existing cardiovascular disease, diabetes, renal impairment, or multiple pregnancies were excluded.
All participants underwent standardized echocardiographic evaluation in accordance with the 2016 recommendations of the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI). Diastolic function was assessed based on transmitral Doppler indices (E and A waves, E/A ratio), tissue Doppler imaging (septal and lateral e' velocities), E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 18-45 years
- •Third trimester of pregnancy
- •Group A: women diagnosed with preeclampsia according to international criteria (blood pressure ≥ 140/90 mmHg after 20 weeks with proteinuria or signs of severity)
- •Group B (controls): normotensive pregnant women without proteinuria or cardiovascular disease
- •Signed informed consent
排除标准
- •Known pre-existing cardiovascular disease (structural heart disease, heart failure, chronic hypertension complicated)
- •Left ventricular ejection fraction < 45%
- •Pre-gestational diabetes
- •Chronic kidney disease
- •Multiple pregnancy
- •Other severe comorbidities that could affect cardiac function independently of preeclampsia
结局指标
主要结局
Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women
时间窗: At baseline, during third-trimester pregnancy hospital evaluation.
Echocardiographic assessment of diastolic function according to ASE/EACVI 2016 criteria, including parameters E, A, E/A ratio, septal and lateral e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity.
次要结局
未报告次要终点
研究者
Ben marzouk Sofiene
Associate Professor of Anesthesiology and Critical Care, Principal Investigator
University Tunis El Manar