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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01192737
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Influenza Pregnancy

Study Design

Study Type : Observational
Actual Enrollment : 919 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
Study Start Date : October 2009
Primary Completion Date : September 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Secondary Outcome Measures :
  1. Safety of Flu vaccine [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Serum, cord blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192737


Locations
France
Maternité Necker-Brune
Paris, France
Maternité Port Royal
Paris, France
Maternité Saint Vincent de Paul
Paris, France
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Odile Launay, MD, PhD CIC de Vaccinologie Cochin Pasteur
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01192737     History of Changes
Other Study ID Numbers: C09-24
2009-015160-34 ( EudraCT Number )
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
pandemic
A/H1N1
pregnancy
cohort
vaccine
Influenza and Pregnancy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases