Influenza Clinical Trial
Official title:
Outcomes of Pandemic Influenza in Pregnancy: an Observational Cohort Study
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.
Subjects will be consented to participate in the study. They will complete a web-based
baseline questionnaire. Participants will be given a nasal swab kit with instructions for
obtaining swabs. Baseline blood (10mls) will be drawn for influenza serology and for
measurement of total IgG and IgG subtypes. An email will be sent to each participant within
24 hours of their enrolment to welcome them to the study.
Participants will be asked to complete a weekly diary using web-based data entry. An email
will be sent to each participant every Monday during the study reminding the participant to
complete their weekly diary and to report and submit a nasal swab if they have any symptoms
of an acute respiratory illness. Reminder emails will be sent 48 hours later if the weekly
form remains incomplete. Participants will be telephoned if forms remain incomplete for
three weeks. Weekly emails will also be used to update participants about vaccine
availability, current vaccine recommendations, and any changes in expert recommendations for
pregnant women.
Once every four weeks additional questions will be asked on the weekly survey. If any
participant develops symptoms compatible with an acute viral respiratory illness they will
be asked to collect and submit a nasal swab as soon as possible after the onset of symptoms
and to complete an illness starting the day of symptom onset and ending when all symptoms
are either absent or mild, or for 3 days, whichever is longer. Subjects will be notified if
results are positive for influenza along with the local Medical Officer of Health. Treatment
for influenza will be discussed with each infected participant by a physician investigator.
Repeat serology and blood for total IgG and IgG subtype will be drawn at the time of
delivery to the six week post partum. Women will notify the study when they are admitted for
delivery or termination of pregnancy and will be interviewed either in person at the
hospital, or over the telephone within 3 weeks of delivery. A chart review will be performed
to identify any complications at delivery or termination, and to record neonatal outcomes.
Post-partum, mothers will continue their own weekly and illness diaries and weekly diaries
for their infants will be added.
Pregnant women requiring hospital admission for influenza in hospitals participating in
surveillance for the Toronto Invasive Bacterial Diseases Network (TIBDN) and Serious
Outcomes Surveillance (SOS) for the PHAC/CIHR Influenza Research Network (PCIRN), as well as
pregnant women with influenza admitted to intensive care units as part of the Canadian
Critical Care Clinical Trials Group Influenza Surveillance System (ICU-Flu) will be
approached. Risk factor data from the baseline and weekly questionnaires will be collected
retrospectively from these women. With consent, women will be followed to
delivery/termination, and the same information collected regarding neonatal outcomes as was
collected for other women in the cohort.
An email will be sent to all participating women requesting their consideration of three
additional parts of the study:
1. A questionnaire of development (the 8 month Ages and Stages® Questionnaire; see
attached) to be completed by the parent
2. An assessment with a physical examination at 7-9 months of age by a trained physician
or a nurse practitioner
3. Permission for the study to contact parents in the future about further follow-up.
Mothers will also be asked to book an appointment for the 7-9 month assessment. Mothers who
do not wish to have a pediatrician assessment will be asked over the telephone if they have
any questions they wish to have answered about the study or the Ages and Stages®
questionnaire, and if they consent to contact for future long term follow-up studies. If the
child's score on the Ages and Stages® questionnaire raises a concern, mothers will be
offered the chance to discuss this with a study physician, to have the results shared with
her child's physician and/or to be referred to a pediatrician.
Participants may choose to withdraw from the study at any time. When they do so, they will
be asked if the data and blood samples that have been provided can be kept and used for
study purposes. If a patient withdraws and cannot be contacted data that has been obtained
will be retained, and blood will be used for the immediate study purpose, but will not be
used for future studies.
;
Observational Model: Cohort, Time Perspective: Prospective
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