Outcomes of Pandemic Influenza in Pregnancy
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Outcomes of Pandemic Influenza in Pregnancy: an Observational Cohort Study|
- Influenza A(H1N1)v infection: will be as diagnosed by polymerase chain reaction(PCR) from nasal or nasopharyngeal (NP) swabs, and/or seroconversion to influenza A(H1H1)v. [ Time Frame: October 2009 to June 2010 ] [ Designated as safety issue: No ]
Primary analysis for risk factors for infection will consider only symptomatic infection, defined as acute respiratory illness/ influenza like illness (fever (at least one measured T>=38°C) and cough and one other local or systemic symptom compatible with influenza) during the pregnancy with seroconversion to A(H1N1)v not explained by vaccination. Seroconversion defined as a 4 fold increase in hemagglutination inhibition titer from 1st to 2nd serum sample.
Symptoms compatible with influenza defined as fever, cough, coryza, generalized myalgias, sore throat, headache, severe fatigue.
- Adverse fetal/neonatal outcome. [ Time Frame: October 2009-June 2010 ] [ Designated as safety issue: No ]Fetal loss >12 weeks, stillbirth, neonatal mortality, significant neonatal morbidity, prematurity, or low birth weight, stillbirth, neonatal mortality, prematurity, live birth at less than 37 weeks gestational age, low birth weight, significant neonatal morbidity, severe congenital malformation, complicated influenza infection.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2012|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322516
|University of Calgary|
|Calgary, Alberta, Canada|
|University of Edmonton|
|Edmonton, Alberta, Canada|
|Canada, British Columbia|
|British Columbia's Women's and Children's Hospital|
|Vancouver, British Columbia, Canada|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Hamilton, Ontario, Canada|
|Public Health Agency of Canada|
|Ottawa, Ontario, Canada|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Principal Investigator:||Shelly McNeil, MD FRCPC||Dalhousie University, Halifax, NS|
|Principal Investigator:||Emmanuel Bujold, MD||Laval University, Montreal, Quebec|
|Principal Investigator:||Allison McGeer, MD FRCPC||University of Toronto, Toronto, Ontario|
|Principal Investigator:||Mark Loeb, MD||McMaster University, Hamiton, Ontario|
|Principal Investigator:||Marie Louie, MD||University of Calgary, Calgary, Alberta|
|Principal Investigator:||George Zahariadis, MD||University of Alberta, Edmonton, Alberta|
|Principal Investigator:||Deborah Money, MDFRCSC||University of British Columbia, Vancouver, British Columbia|
|Principal Investigator:||Rachel Rodin, MD||Public Health Agency of Canada, Ottawa, Ontario|