Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
1 other identifier
interventional
600
1 country
1
Brief Summary
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 4, 2018
December 1, 2018
6 years
May 4, 2017
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
UA PI change before and after maternal hyperoxygenation
10-15 minutes
Other Outcomes (3)
Response of myocardial diastolic function to MH in various forms of CHD
10-15 minutes
Systolic function change before and after MH
10-15 minutes
Changes in flow pattern at the aortic isthmus
10-15 minutes
Study Arms (1)
Maternal Hyperoxygenation
OTHERMaternal hyperoxygenation will be offered by administering 10 liters nasal cannula by face-mask (approximately 60% fiO2) for a minimum of 10 minutes.
Interventions
approximately 10-15 minutes of maternal hyperoxygenation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijng Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yihua He, MD
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Ultrosound
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 10, 2017
Study Start
January 1, 2016
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
December 4, 2018
Record last verified: 2018-12