Clinical trial NCT01374009: H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009
Official title: H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vaccine Exposure During Pregnancy
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: Li Ka Shing Foundation
name: PHAC/CIHR Influenza Research Network
First posted: 2011-06-15
Enrollment: 504
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who recieved the H1N1 vaccine during pregnancy in 2009.

Brief summary: The goal of this study it to rapidly create a brief registry of pregnant women who receive the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1 2009/2010 influenza season.

Detailed description: For Part 1, a brief amount of data will be collected on each woman at the time of her vaccination. These data will be filled out on a single data collection sheet by her Obstetrics Clinic physician or nurse, which will be completed at the time of her vaccination.

For Part 2, after a woman's expected delivery date, data sources will be used for participants. Two groups of non-vaccinated controls will be derived from the provincial perinatal databases:

1. The active non-vaccinated controls will be recruited from the concurrent year, matched to women who were vaccinated in 2009/2010. For each of the three perinatal databases, 5 non-vaccinated active controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
2. The passive non-vaccinated controls will be derived from the preceding year (i.e., 2008). For each of the three perinatal databases, 5 non-vaccinated passive controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.

For women who delivered in Ontario, the Niday Perinatal Database will be used. (https://www.nidaydatabase.com/info/index.shtml).

For women who deliver in British Columbia, their data will be linked to the British Columbia Perinatal Database Registry (http://www.bcphp.ca/Database%20Content.htm). Women who deliver in Nova Scotia will be linked to Nova Scotia Atlee Perinatal Database (http://rcp.nshealth.ca/rcp_3347.html).

Information that will be obtained is as follows:

* Actual delivery date (DD/MM/YYYY)
* Number of infants delivered
* Mode of delivery (vaginal for Caesarean)
* Liveborn or stillborn
* Presence of a congenital anomaly
* Presence of intrauterine growth restriction or small-for-gestational age birthweight
* Presence of a neonatal infection
* Presence of neonatal sepsis
* Need for ventilation of the neonate
* Need for Neonatal Intensive Care of the Neonate.

For Part 3, between 18-24 months after a woman's actual delivery date, a woman may be telephoned at her home to ask her about the health and developmental milestones of her baby. This phase may or may not be done, but consent will be obtained nonetheless.

Eligibility criteria: Inclusion Criteria:

* Received the H1N1 vaccine during pregnancy

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre, University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Toronto
country: Canada
facility: Li Ka Shing Knoweldge Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre and Women's College Hospital
state: Ontario
Study officials:
affiliation: Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS
name: Shelly A McNeil, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital/University of Toronto, Toronto, Ontario
name: Joel Ray, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital/University of Toronto, Toronto, Ontario
name: Alison McGeer, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia, Vancouver, British Columbia
name: Deborah Money, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's Inversity, Kingston, Ontario
name: Graeme N Smith, MD PhD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre and Women's College Hospital, University of Toronto
name: Jennifer Blake, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, University of Toronto, Toronto, Ontario
name: Mark Yudin, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario
name: Muhammad Mamdani, PharmD MPH
role: PRINCIPAL_INVESTIGATOR
References: