A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Pulmonary artery pressures
研究概览
简要总结
In this study, the investigators will follow two small cohorts of pregnant women: a cohort of healthy women with uncomplicated pregnancies residing at high altitude, a control group of healthy women with uncomplicated pregnancies residing at sea level, to characterize differences in cardiopulmonary adaptation and nitric oxide (NO) pathway expression at elevations >3,500 m throughout pregnancy and into the postpartum period. The investigators aim to investigate right-sided cardiac impairment induced by chronic hypobaric hypoxemia, its effects on fetal growth, and the potential contribution of cardiovascular nitric oxide depletion to obstetric complications.
详细描述
To investigate cardiac impairment, the investigators will perform transthoracic echocardiography in all enrolled pregnant women and infants, with a focus on right-sided cardiac anatomy and function, including pulmonary artery pressures, right ventricular thickness, right ventricular systolic performance, and indices of pulmonary vascular load.
To investigate the effects of hypobaric hypoxia on fetal growth, the investigators will measure intrauterine and post-delivery growth parameters, assess placental weight and histologic features, and correlate these findings with maternal oxygenation status and altitude exposure.
To assess nitric oxide production and consumption, the investigators will quantify nitric oxide-related metabolites (NO metabolomics) in maternal blood, umbilical cord blood, and placental tissue in both cohorts, and correlate these biomarkers with pulmonary arterial pressures, and right ventricular function. The investigators will also assess flow-mediated dilation in the high altitude cohort and relate these measures of endothelial function to pulmonary vascular and obstetric outcomes.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women delivering at participating hospitals at more than 3500 meters or women delivering at participating hospitals at sea level
- •signed informed consent
排除标准
- •preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA > III)
结局指标
主要结局
Pulmonary artery pressures
时间窗: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)
Measurement will be performed by transthoracic echocardiography.
Nitric oxide metabolites
时间窗: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks) for maternal samples, at delivery (neonatal samples)
Measurement will be performed with a chemiluminescence assay.
Echographic estimate of fetal weight
时间窗: Late pregnancy (35 ± 4 weeks gestation)
RV remodeling echocardiography parameters
时间窗: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)
Weight at birth
时间窗: At delivery
次要结局
未报告次要终点
研究者
Lorenzo Berra, MD
PI
Massachusetts General Hospital