"COhort Study on A/H1N1 FLU During PREGnancy"

Completed

• Conditions: Pregnancy; Influenza

• Registration Number: NCT01192737
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-08-31
• Primary Completion: 2010-09
• Study First Posted: 2010-09-01
• Study Completion: 2010-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 919

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.	1 year

Secondary Outcome Measures

Name	Time	Method
Safety of Flu vaccine	1 year

Trial Locations

Locations (3)

Maternité Saint Vincent de Paul; 🇫🇷 Paris, France

Maternité Necker-Brune; 🇫🇷 Paris, France

Maternité Port Royal; 🇫🇷 Paris, France