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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


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
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