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Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03147014
Enrollment
600
Registered
2017-05-10
Start date
2016-01-01
Completion date
2022-12-31
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Coarctation, Atrial Septal Aneurysm, Hypoplastic Left Heart Syndrome

Keywords

Echocardiography, Congenital Heart Disease, Maternal hyperoxygenation

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.

Interventions

approximately 10-15 minutes of maternal hyperoxygenation

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
MCA PI change before and after maternal hyperoxygenation10-15 minutesThe 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.

Secondary

MeasureTime frameDescription
UA PI change before and after maternal hyperoxygenation10-15 minutesResponse 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.

Other

MeasureTime frameDescription
Response of myocardial diastolic function to MH in various forms of CHD10-15 minutesDiastolic 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 MH10-15 minutesany 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 isthmus10-15 minutesChanges in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta

Countries

China

Contacts

Primary ContactYanping Ruan, MD
yanping.ruan@163.com+86 15311258732
Backup ContactYihua He, MD
heyihuaecho@hotmail.com+86 18910778673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026