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临床试验/NCT04053296
NCT04053296Unknown不适用

Morbidity and Outcomes of Pregnant Women With Pulmonary Arterial Hypertension During Different Pregnancies

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Death

研究概览

简要总结

The investigators intend to explore the characteristics and outcomes of pregnant women with PAH during different pregnancies and to provide applicable evidence for clinical practice.

详细描述

Pulmonary arterial hypertension (PAH) is a fatal disease with progressive vascular resistance that leads to the loss of right heart function. Avoiding pregnancy is essential for PAH women. In recent years, maternal mortality in pregnant women with PAH has decreased mostly due to emerging advanced therapies for PAH and the progress in high-risk pregnancy management. Nevertheless, the maternal death rate in parturients with PAH remains high; therefore, contraception is still recommended for women diagnosed with PAH. However, some women develop this condition during pregnancy. With the two-child policy, families in China are allowed to have a second child. As a result, the number of PAH diagnoses during pregnancy may increase with the general increase in the number of pregnant women. Additionally, some patients develop PAH only during their second pregnancy. In order to investigate the incidence and clinical characteristics of pregnant women diagnosed with PAH during different pregnancies, this observational study aimed to analyze perinatal and pregnancy clinical data, to compare the perinatal status and maternal and infant outcomes of the first and second pregnancies complicated with PAH, establishing a clinical basis for the prenatal consultation, diagnosis, and treatment of pregnant women with PAH.

研究设计

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

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

  • PAH was screened by Doppler echocardiography first. Echocardiographic criteria for the diagnosis of PAH included tricuspid regurgitation velocity >2.8 m/sec, with extra more than one additional echocardiographic sign

排除标准

  • Cases of PH diagnosed before pregnancy, secondary to chronic lung disease, and left heart disease, as well as right ventricular outflow tract obstruction and congenital pulmonary stenosis.

结局指标

主要结局

Death

时间窗: 10 year

The patient die at any time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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