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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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19 February 2015 |
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Main ID: |
NCT01192737 |
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Date of registration:
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20/07/2010 |
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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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"COhort Study on A/H1N1 FLU During PREGnancy"
COFLUPREG |
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Scientific title:
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Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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919 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01192737 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Odile Launay, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CIC de Vaccinologie Cochin Pasteur |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- > 18 years
- Pregnancy between 12 and 35 weeks of gestation, going in one of the following
maternity cares: Port Royal, Necker, Saint Vincent de Paul
- Provides written informed consent
- Speaks and understands French
- Covered by French Social Security
Exclusion Criteria:
- Not covered by French Social Security
- Previous H1N1 influenza (virologically documented)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Influenza
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Primary Outcome(s)
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Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Safety of Flu vaccine
[Time Frame: 1 year]
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Secondary ID(s)
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2009-015160-34
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C09-24
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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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