"COhort Study on A/H1N1 FLU During PREGnancy"

NCT ID: NCT01192737

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

919 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Odile Launay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CIC de Vaccinologie Cochin Pasteur

Locations

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Maternité Necker-Brune

Paris, , France

Site Status

Maternité Port Royal

Paris, , France

Site Status

Maternité Saint Vincent de Paul

Paris, , France

Site Status

Countries

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France

References

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Launay O, Krivine A, Charlier C, Truster V, Tsatsaris V, Lepercq J, Ville Y, Avenell C, Andrieu T, Rozenberg F, Artiguebielle F, Treluyer JM, Goffinet F; Inserm COFLUPREG Study Group. Low rate of pandemic A/H1N1 2009 influenza infection and lack of severe complication of vaccination in pregnant women: a prospective cohort study. PLoS One. 2012;7(12):e52303. doi: 10.1371/journal.pone.0052303. Epub 2012 Dec 27.

Reference Type RESULT
PMID: 23300637 (View on PubMed)

Other Identifiers

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2009-015160-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C09-24

Identifier Type: -

Identifier Source: org_study_id

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