NCT03147014

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Detailed description

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.

Conditions

• Hypoplastic Left Heart Syndrome
• Aortic Coarctation
• Atrial Septal Aneurysm

Interventions

Type	Name	Description
BIOLOGICAL	Maternal hyperoxygenation	approximately 10-15 minutes of maternal hyperoxygenation

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2017-05-10
• Last updated: 2018-12-04

Locations

1 site across 1 country: China