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Completed

NCT Number: NCT01192737

"COhort Study on A/H1N1 FLU During PREGnancy"

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections Pregnancy RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maternité Necker-Brune, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Safety of Flu vaccine

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: COFLUPREG

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2010
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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