"COhort Study on A/H1N1 FLU During PREGnancy"

Pregnancy Clinical Trial

— COFLUPREG  

Official title:

Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192737
• Other study ID #: C09-24
• Secondary ID: 2009-015160-34
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: April 16, 2012
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 919
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Pregnancy

Locations

Country	Name	City	State
France	Maternité Necker-Brune	Paris
France	Maternité Port Royal	Paris
France	Maternité Saint Vincent de Paul	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.		1 year	Yes
Secondary	Safety of Flu vaccine		1 year	Yes