Clinical trial NCT03147014: Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Official title: Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoplastic Left Heart Syndrome
Aortic Coarctation
Atrial Septal Aneurysm
Keywords: Echocardiography
Congenital Heart Disease
Maternal hyperoxygenation
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: MCA PI change before and after maternal hyperoxygenation
timeFrame: 10-15 minutes
Secondary outcomes:
measure: UA PI change before and after maternal hyperoxygenation
timeFrame: 10-15 minutes
Other outcomes:
measure: Response of myocardial diastolic function to MH in various forms of CHD
timeFrame: 10-15 minutes
measure: Systolic function change before and after MH
timeFrame: 10-15 minutes
measure: Changes in flow pattern at the aortic isthmus
timeFrame: 10-15 minutes
Locations:
city: Beijing
country: China
facility: Beijng Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yihua He, MD
role: STUDY_DIRECTOR
References: