P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- change in the range of P-wave Duration and Dispersion
研究概览
简要总结
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
详细描述
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease. The most frequent laboratory abnormality is elevation of serum bile acid levels in ICP.
Bile acids increases both maternal and fetal circulation in ICP. The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus.
P-wave dispersion (PWD) is defined as the difference between the maximum and the minimum P-wave durations measured on a 12-lead surface electrocardiogram (ECG). Increased P-wave duration and PWD have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity.
So the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
The aim of this study is to investigate maternal P-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnants who with ICP
排除标准
- •Chronic liver disease
- •Disease during current pregnancy
- •Multiple pregnancies
结局指标
主要结局
change in the range of P-wave Duration and Dispersion
时间窗: one year
A 12-lead surface ECG will obtain for all pregnants with icp in the supine position after a rest period of 10 minutes. Two consecutive cycles will record at a speed of 50 mm/sec and with an amplitude of 10mm/mV. All ECGs will examine by a designated cardiologist blinded to patient details. To improve accuracy, measurements will made using calipers and magnifying lens. Only participants with normal sinus rhythm on ECG will include in the final analysis
次要结局
未报告次要终点
研究者
Ayse Kirbas
ayse kirbas
Zekai Tahir Burak Women's Health Research and Education Hospital