跳至主要内容
临床试验/NCT06004544
NCT06004544招募中不适用

Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women

National Institute of Cardiovascular Diseases, Pakistan1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Number of participants found to have abnormal left ventricular function

研究概览

简要总结

Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method.

详细描述

Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left ventricular (LV) function was quantified using biplane Simpson's method and visually assessed by two independent readers. Patients with significant valve disease or congenital heart disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and long-term follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Obstetric patients attending routine antenatal visits

排除标准

  • Patients refused to give consent for echocardiography or participation in the study

结局指标

主要结局

Number of participants found to have abnormal left ventricular function

时间窗: At the time of screening echocardiogram

Prevalence of Left ventricular dysfunction (Ejection Fraction\<55%)

Number of participants found to have abnormal heart valve function

时间窗: At the time of screening echocardiogram

Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)

次要结局

  • Number of participants found to have adverse Maternal outcomes(At the time of delivery)
  • Number of participants found to have adverse Fetal outcomes(At the time of delivery)

研究者

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

Sabha Bhatti

Professor

National Institute of Cardiovascular Diseases, Pakistan

研究点 (1)

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