COhort Study on A/H1N1 FLU During PREGnancy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01192737

Acronym

COFLUPREG

Enrollment

919

Registered

2010-09-01

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Pregnancy

Keywords

pandemic, A/H1N1, pregnancy, cohort, vaccine, Influenza and Pregnancy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Safety of Flu vaccine	1 year

Countries

France

Outcome results