Current Status of Diagnosis and Treatment of Pregnancy With Pulmonary Hypertension and Maternal and Infant Outcomes: a Multicentre Retrospective Study in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- all-cause maternal mortality
研究概览
简要总结
Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with pulmonary hypertension in China. Eligible samples were screened from January, 2012 to December, 2021. Maternal clinical characteristics and in-and-out hospital outcomes were collected and compared in women with and without pulmonary hypertension.
The main aims of this study are as follows:
- To investigate the perinatal diagnosis and treatment of pregnant women with pulmonary hypertension in China over the past 10 years and the maternal and infant outcomes.
- To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants.
- To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy.
- To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.
详细描述
Pulmonary hypertension is a malignant disease with a high mortality rate, difficult to diagnose at an early stage and has posed a huge economic burden on patients and society. Pregnancy with pulmonary hypertension is associated with high maternal mortality (25% - 56% ) and a high incidence of fetal complications such as preterm birth (85% - 100%), fetal growth restriction (3% - 33%) and severe outcomes such as fetal/neonatal loss (7% - 13%). A high maternal mortality rate of 30%-56% for pregnancy-related pulmonary hypertension for women and 11-28% for infants has been reported.
However, despite national and international guidelines recommending avoidance of pregnancy, some women with pulmonary hypertension persist in their pregnancies or have unplanned pregnancies, and some pregnant women are diagnosed with pulmonary hypertension only after symptoms such as heart failure have worsened. Although with the development of pulmonary arterial hypertension(PAH)-targeted drugs, the mortality rate for pregnancy-associated PAH has declined but remains relatively high. The high maternal and infant mortality rates and complication rates make it a critical condition that seriously endangers the lives of both mother and child.
Limited data in China reported the outcome, prognosis and management measures of combined pulmonary hypertension in pregnancy, and there is a lack of overall description and analysis of pregnancy with pulmonary hypertension in a multi-centre setting. The current status of high risk factors, efficacy of multidisciplinary consultation and management of maternal and fetal mortality and complications is unclear.
Therefore, the aim of this study was to retrospectively analyse the current status of the management of pregnant women with pulmonary hypertension in a multicenter setting across China, and try to summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy to reduce maternal and infant mortality and adverse events and improve the prognosis of mothers and infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women, regardless of age, race
- •diagnosed with pulmonary hypertension(PH) before pregnancy or during pregnancy
- •diagnosed with PH by right heart catheterization or echocardiography
- •diagnostic criteria of right heart catheterization: mean pulmonary artery pressure (mPAP) ≥ 25 mm Hg by right heart catheterization at rest
- •diagnostic criteria of echocardiography: pulmonary artery systolic pressure (PASP)≥40 mm Hg
- •time: from January 1, 2012 to December 31, 2021
排除标准
- •Patients with isolated exercise-induced PH (mean PAP <25 mm Hg at rest and >30 mm Hg at exercise) were excluded.
- •pulmonary artery systolic pressure (PASP)<40 mmHg by echocardiography
- •mean pulmonary artery pressure (mPAP) < 25 mm Hg by right heart catheterization at rest
结局指标
主要结局
all-cause maternal mortality
时间窗: diagnosis of pregnancy to six months postpartum in 2012-2021
Investigating the maternal mortality rate from the diagnosis of pregnancy to six months postpartum
次要结局
- Maternal incidence of cardiovascular complications(from diagnosis of pregnancy to six months postpartum in 2012-2021)
- the incidence of obstetric events(From delivery to 42 days postpartum)
- the incidence of fetal events(From delivery to 42 days postpartum)
研究者
Wei Huang
Professor Wei Huang
First Affiliated Hospital of Chongqing Medical University