An interventional study of Maternal hyperoxygenation in Hypoplastic Left Heart Syndrome, Aortic Coarctation and Atrial Septal Aneurysm, sponsored by Beijing Anzhen Hospital. Status unknown at 1 site in China. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Prevention
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
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.
Exclusion Criteria:
Maternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes.
Biological: Maternal hyperoxygenation
approximately 10-15 minutes of maternal hyperoxygenation
MCA PI change before and after maternal hyperoxygenation
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.
Time frame: 10-15 minutes
UA PI change before and after maternal hyperoxygenation
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.
Time frame: 10-15 minutes
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.
Time frame: 10-15 minutes
Systolic function change before and after MH
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.
Time frame: 10-15 minutes
Changes in flow pattern at the aortic isthmus
Changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta
Time frame: 10-15 minutes
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Anzhen Hospital