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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
Sponsor:
Information provided by (Responsible Party):
He Yihua,MD, Beijing Anzhen Hospital

Brief Summary:
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease

Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Aortic Coarctation Atrial Septal Aneurysm Biological: Maternal hyperoxygenation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Yanping Ruan, MD +86 15311258732 yanping.ruan@163.com
Contact: Yihua He, MD +86 18910778673 ext +8618910778673 heyihuaecho@hotmail.com

Locations
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China, Beijing
Beijng Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Wei Li, MD    +86 15901281629    anzhenyuanban@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Study Director: Yihua He, MD Beijing Anzhen Hospital

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Responsible Party: He Yihua,MD, Director of Department of Ultrosound, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03147014     History of Changes
Other Study ID Numbers: MH-FCHD01
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by He Yihua,MD, Beijing Anzhen Hospital:
Echocardiography
Congenital Heart Disease
Maternal hyperoxygenation
Additional relevant MeSH terms:
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Heart Diseases
Aneurysm
Hypoplastic Left Heart Syndrome
Aortic Coarctation
Cardiovascular Diseases
Vascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities