Comparison Between Invasive and Non-invasive Assessment of Blood Pressure in Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- assess accuracy of non-invasive central blood pressure
研究概览
简要总结
Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality worldwide. Hypertension is one of the most commonly reported health conditions among pregnant women and complicates 5-10% of all pregnancies.(Martin et al., 2009) (Wagner et al., 2007) The measurement of central BP in hypertensive patients became more important because of its predictive value for cardiovascular events. Direct intra-arterial readings are considered to be the gold standard method for blood pressure measurement but because arterial cannulation is associated with risks, alternative non-invasive blood pressure measurements may be used. (Araghi et al., 2006) In our study, the investigator aimed to assess the accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy.
the investigators enrolled 100 pregnant women and 10 healthy non-pregnant women as a control group, central blood pressure was measured invasively by arterial cannula and non-invasively by oscillometric automated device (Mobil O Graph).
the investigatorshave found a high correlation between non-invasive central blood pressure measurements and invasively measured both systolic (r 0.968, p=0.000) and diastolic (r 0.687, p=0.000).
详细描述
Study Methods:
All patients included in our study were subjected to the following:
- Full history taking including:
Age, full obstetric history including (number of previous pregnancies and abortions), history of previous illness, duration of pregnancy.
Risk factors for developing hypertension as Diabetes Mellitus (DM), history of chronic hypertension, anti-hypertensive treatment, history of HTN during previous pregnancies. 2. Full physical examination:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All Pregnant women diagnosed to have hypertensive disorders of pregnancy (chronic HTN, gestational HTN, pre-eclampsia or eclampsia) after control of hypertension using anti-hypertensive drugs.
排除标准
- •Patients with previous cardiac diseases.
- •Chronic kidney disease (CKD) which is defined as kidney damage or glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause.
- •Any disease requiring the use of anti-inflammatory medication, any other endocrine disease such as hyperthyroidism.
- •Conditions that prevent invasive blood pressure measurement (arterial cannulation) as severe bleeding disorders.
- •Patients refusing to join the study.
- •Any associated severe comorbidities have been excluded.
结局指标
主要结局
assess accuracy of non-invasive central blood pressure
时间窗: 12 months
to assess accuracy of non-invasive central blood pressure by oscillometric automated device (Mobil O graph) in comparison to the invasive blood pressure measurement by arterial cannulation in patients with hypertensive disorders in pregnancy
次要结局
未报告次要终点
研究者
Ayman Khairy Mohamed Hassan
assistant professor
Assiut University