"COhort Study on A/H1N1 FLU During PREGnancy"

N/ACompletedNCT01192737

Institut National de la Santé Et de la Recherche Médicale, France919 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

919

Conditions

Influenza Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Maternité Necker-Brune

Paris, France

Maternité Port Royal

Paris, France

Maternité Saint Vincent de Paul

Paris, France

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

Time frame: 1 year

Data from ClinicalTrials.gov

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