NCT01192737CompletedNot Applicable
Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
Institut National de la Santé Et de la Recherche Médicale, France3 sites in 1 country919 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 919
- Locations
- 3
- Primary Endpoint
- Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
Study Overview
Brief Summary
The purpose of this study is to measure the incidence of A/H1N1 Influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in Paris, France.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
Time Frame: 1 year
Secondary Outcomes
- Safety of Flu vaccine(1 year)
Investigators
Study Sites (3)
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