"COhort Study on A/H1N1 FLU During PREGnancy" (COFLUPREG)

April 16, 2012 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

919

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Maternité Port Royal
      • Paris, France
        • Maternité Necker-Brune
      • Paris, France
        • Maternité Saint Vincent de Paul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of A/H1N1 Influenza virus infection in pregnant women and impact of Flu on pregnancy outcome.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of Flu vaccine
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Odile Launay, MD, PhD, CIC de Vaccinologie Cochin Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C09-24
  • 2009-015160-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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