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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03147014 |
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Date of registration:
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04/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
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Scientific title:
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Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease |
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Date of first enrolment:
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January 1, 2016 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03147014 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Yihua He, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Anzhen Hospital |
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Name:
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Wei Li, MD |
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Address:
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Telephone:
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+86 15901281629 |
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Email:
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anzhenyuanban@163.com |
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Affiliation:
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Name:
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Yanping Ruan, MD |
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Address:
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Telephone:
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+86 15311258732 |
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Email:
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yanping.ruan@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hypoplastic Left Heart Syndrome
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Atrial Septal Aneurysm
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Aortic Coarctation
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Intervention(s)
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Biological: Maternal hyperoxygenation
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Primary Outcome(s)
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MCA PI change before and after maternal hyperoxygenation
[Time Frame: 10-15 minutes]
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Secondary Outcome(s)
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UA PI change before and after maternal hyperoxygenation
[Time Frame: 10-15 minutes]
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Secondary ID(s)
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MH-FCHD01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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