Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- MCA PI change before and after maternal hyperoxygenation
研究概览
简要总结
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
详细描述
The purpose of this study is to investigate the phenomenon of cardiovascular system response to maternal hyperoxygenation in the fetus with congenital heart disease(CHD), which can provide further insight into fetal adaptations to CHD and improve our understanding of the pathophysiology of these conditions.Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography various gestational weeks.The baseline fetal echocardiography parameters has obtained from these gravidas.Then the participants received 10-15 minutes hyperoxygenation, and the accordingly fetal echocardiography parameters were obtained.The objective of the study includes:(1)To investigate the response of the MCA PI to maternal hyperoxygenation in various forms of CHD. Middle cerebral artery(MCA) pulsatility index (PI) at MH will be compared to baseline at various gestational ages in a variety of types of CHD;(2)To investigate the response of the umbilical artery (UA) PI to maternal hyperoxygenation in various forms of CHD. UA PI at MH will be compared to baseline at various gestational ages in a variety of CHD; (3)To study the response of myocardial diastolic function to MH in various forms of CHD. Diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at MH and compared to baseline at various gestational ages in a variety of CHD;(4)To investigate for any changes in cardiac output and the ratio of flow between the right and left ventricles in response to MH in various forms of CHD;(5)To investigate for changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All singleton fetuses with CHD at all gestational ages are eligible for enrollment in the study. Patients will be recruited to enroll in the study as they present for clinical care at Fetal Echocardiography clinic. MH assessments will all be performed only at the Beijing Anzhen Hospital. Baseline room air data for CHD may be collected from other referring centers within the Anzhen network.
排除标准
- •Non-sinus rhythm, presence of arrhythmia; Fetal hydrops; Severe brain anomaly (which may influence MCA flow); Evidence for significant ventricular dysfunction; Evidence for constriction of the ductus arteriosus
研究组 & 干预措施
Maternal Hyperoxygenation
Maternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes.
干预措施: Maternal hyperoxygenation (Biological)
结局指标
主要结局
MCA PI change before and after maternal hyperoxygenation
时间窗: 10-15 minutes
The response of the MCA PI to maternal hyperoxygenation in various forms of CHD. MCA PI at MH will be compared to baseline at various gestational ages in a variety of types of CHD.
次要结局
- UA PI change before and after maternal hyperoxygenation(10-15 minutes)
研究者
He Yihua,MD
Director of Department of Ultrosound
Beijing Anzhen Hospital
