Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Study Overview

• Status: Recruiting
• Conditions: Hypoplastic Left Heart Syndrome; Aortic Coarctation; Atrial Septal Aneurysm
• Intervention / Treatment: Biological: Maternal hyperoxygenation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihua He, MD; Phone Number: +8618910778673 +86 18910778673; Email: heyihuaecho@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijng Anzhen Hospital
      • Contact: Wei Li, MD; Phone Number: +86 15901281629; Email: anzhenyuanban@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Maternal Hyperoxygenation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-15 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	10-15 minutes

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Study Director: Yihua He, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Echocardiography; Maternal hyperoxygenation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Aneurysm; Hypoplastic Left Heart Syndrome; Aortic Coarctation
• Other Study ID Numbers: MH-FCHD01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No