"COhort Study on A/H1N1 FLU During PREGnancy" | NCT01192737

Studies
"COhort Study on A/H1N1 FLU During PREGnancy"

NCT01192737

Sponsor

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

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

919Actual

Phase

Not provided

Conditions

Influenza
Pregnancy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-015160-34	EudraCT Number

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

919Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety of Flu vaccine		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Odile Launay, MD, PhD	CIC de Vaccinologie Cochin Pasteur	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternité Necker-Brune		Paris			France
Maternité Port Royal

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23300637	Result	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.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections