The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Systolic Cardiac Function
研究概览
简要总结
The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.
详细描述
While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.
The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Available for assessment within the neonatal period,
- •Parent is willing and able to give informed consent for participation in the study,
- •Physical condition is suitable to allow non-invasive vascular testing,
- •Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged >/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
- •Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (<37 weeks gestation)
- •Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (>37 weeks gestation)
排除标准
- •Parent is unwilling to give consent,
- •Unavailable for assessment of cardiovascular system,
- •Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
- •Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
- •Cardiorespiratory instability at time of proposed measures,
- •Active infection at time of proposed study measures,
- •Mother of infant is excluded from the study. (Aged <16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)
结局指标
主要结局
Systolic Cardiac Function
时间窗: Birth and 3 months
Cardiac Function will be assessed by ECHO at birth and 3 months
次要结局
- Heart rate variability(Birth and 3 months)
- Micro-vascular Structure(Birth and 3 months)
- Cardiac diastolic function(Birth and 3 months)
- Blood pressure(Birth and 3 months)
- Pulse wave velocity and pulse-wave analysis(Birth and 3 months)
- Cardiac Structure(Birth and 3 months)