Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT03147014|
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypoplastic Left Heart Syndrome Aortic Coarctation Atrial Septal Aneurysm||Biological: Maternal hyperoxygenation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
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 [ Time Frame: 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.
- UA PI change before and after maternal hyperoxygenation [ Time Frame: 10-15 minutes ]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.
- Response of myocardial diastolic function to MH in various forms of CHD [ Time Frame: 10-15 minutes ]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.
- Systolic function change before and after MH [ Time Frame: 10-15 minutes ]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.
- Changes in flow pattern at the aortic isthmus [ Time Frame: 10-15 minutes ]Changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147014
|Contact: Yanping Ruan, MD||+86 email@example.com|
|Contact: Yihua He, MD||+86 18910778673 ext +firstname.lastname@example.org|
|Beijng Anzhen Hospital||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Wei Li, MD +86 15901281629 email@example.com|
|Study Director:||Yihua He, MD||Beijing Anzhen Hospital|