- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01322516
Outcomes of Pandemic Influenza in Pregnancy
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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:
- A questionnaire of development (the 8 month Ages and Stages® Questionnaire; see attached) to be completed by the parent
- An assessment with a physical examination at 7-9 months of age by a trained physician or a nurse practitioner
- 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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá
- University of Calgary
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Edmonton, Alberta, Canadá
- University of Edmonton
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British Columbia
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Vancouver, British Columbia, Canadá
- British Columbia's Women's and Children's Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3K 6R8
- Queen Elizabeth Ii Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canadá
- McMaster University
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Ottawa, Ontario, Canadá
- Public Health Agency of Canada
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Toronto, Ontario, Canadá
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Canadá
- Laval University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
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
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
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.
Periodo de tiempo: October 2009 to June 2010
|
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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adverse fetal/neonatal outcome.
Periodo de tiempo: October 2009-June 2010
|
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.
|
October 2009-June 2010
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shelly McNeil, MD FRCPC, Dalhousie University, Halifax, NS
- Investigador principal: Emmanuel Bujold, MD, Laval University, Montreal, Quebec
- Investigador principal: Allison McGeer, MD FRCPC, University of Toronto, Toronto, Ontario
- Investigador principal: Mark Loeb, MD, McMaster University, Hamiton, Ontario
- Investigador principal: Marie Louie, MD, University of Calgary, Calgary, Alberta
- Investigador principal: George Zahariadis, MD, University of Alberta, Edmonton, Alberta
- Investigador principal: Deborah Money, MDFRCSC, University of British Columbia, Vancouver, British Columbia
- Investigador principal: Rachel Rodin, MD, Public Health Agency of Canada, Ottawa, Ontario
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 114231
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