Outcomes of Pandemic Influenza in Pregnancy

NCT01322516 | Unknown

• 1 other identifier: 114231
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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

Influenza

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  October 2009 to June 2010

Secondary Outcomes (1)

• Adverse fetal/neonatal outcome.

  October 2009-June 2010

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

800 pregnant women followed through pregnancy during second and third waves of the 2009 influenza pandemic, and 2009/10 influenza season. Forty percent are high risk pregnancies: either for maternal influenza complications (eg. underlying asthma, gestational diabetes mellitus in prior pregnancies) or high risk for obstetrical complications (eg. prior premature birth, multiple pregnancies). Recruitment from Halifax, Quebec City, Toronto, Hamilton, Calgary, Edmonton, and Vancouver. Plan to enroll all women before the beginning of the second wave; however, enrolment of women \<20 weeks pregnant will continue at each site until the second wave has peaked locally.

You may qualify if:

• Participants must:
• be and pregnant, and, at the time of enrolment, not more than 30 weeks gestation.
• be greater than or equal to 16 years of age
• give written informed consent prior to entry
• be available for follow-up during the study period
• have convenient access to a computer with internet access
• know basic skills for use of the internet
• have the ability to complete questionnaires in either English or French

You may not qualify if:

• None

Sponsors & Collaborators

• Dalhousie University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (8)

University of Calgary

Calgary, Alberta, Canada

Location

University of Edmonton

Edmonton, Alberta, Canada

Location

British Columbia's Women's and Children's Hospital

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

Public Health Agency of Canada

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Laval University

Montreal, Quebec, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swabs and serum

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: September 1, 2009
• Study Completion: September 1, 2012
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

CA (8)