Outcomes of Pandemic Influenza in Pregnancy

NCT01322516 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2011-06-15

No results posted yet for this study

Summary

We propose to follow a cohort of pregnant and post-partum Canadian women through the fall and winter of 2009/2010 and the anticipated second and third waves of the current pandemic in order to better understand the incidence, complications and risk factors for severe disease due to H1N1 influenza in pregnant women, and to contribute data on the safety and effectiveness of antivirals and vaccines in this population.

The primary hypotheses to be tested are:

(i) pandemic influenza infection in the second and third trimester of pregnancy is associated with an increase in adverse fetal outcomes (fetal loss, stillbirth, neonatal mortality, significant neonatal morbidity, prematurity) (ii) close contact with young children (\<2 yrs) at home or work is the most important risk factor for influenza in pregnant women (iii) higher scores on a scale of community infection prevention (a combination of self-reported hand hygiene adherence, avoidance of ill persons and avoidance of crowds) are protective against influenza (iv) receipt of seasonal influenza vaccine from 2007 to 2009 will increase the risk of illness due to influenza A(H1N1)v in the second and third waves of the pandemic.

(v) pandemic influenza vaccine is effective in preventing symptomatic influenza in pregnant women.

(vi) vaccination of pregnant women against a particular strain of influenza protects their infants against influenza infection in the first six months of life.

Conditions

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Dalhousie University

    lead OTHER

Principal Investigators

  • Shelly McNeil, MD FRCPC · Dalhousie University, Halifax, NS

  • Emmanuel Bujold, MD · Laval University, Montreal, Quebec

  • Allison McGeer, MD FRCPC · University of Toronto, Toronto, Ontario

  • Mark Loeb, MD · McMaster University, Hamiton, Ontario

  • Marie Louie, MD · University of Calgary, Calgary, Alberta

  • George Zahariadis, MD · University of Alberta, Edmonton, Alberta

  • Deborah Money, MDFRCSC · University of British Columbia, Vancouver, British Columbia

  • Rachel Rodin, MD · Public Health Agency of Canada, Ottawa, Ontario

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Completion
2012-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322516 on ClinicalTrials.gov