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Clinical Trials/NCT01192737
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

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (3)

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