H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Dalhousie University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Li Ka Shing Foundation
PHAC/CIHR Influenza Research Network
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT01374009
First received: June 14, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition
Vaccine Exposure During Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009

Further study details as provided by Dalhousie University:

Enrollment: 504
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women who recieved the H1N1 vaccine during pregnancy in 2009.

Criteria

Inclusion Criteria:

  • Received the H1N1 vaccine during pregnancy

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374009

Locations
Canada, British Columbia
Children's and Women's Health Centre, University of British Columbia
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre and Women's College Hospital
Toronto, Ontario, Canada
Li Ka Shing Knoweldge Institute
Toronto, Ontario, Canada
Sponsors and Collaborators
Dalhousie University
Li Ka Shing Foundation
PHAC/CIHR Influenza Research Network
Investigators
Principal Investigator: Shelly A McNeil, MD FRCPC Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS
Principal Investigator: Joel Ray, MD FRCPC St. Michael's Hospital/University of Toronto, Toronto, Ontario
Principal Investigator: Alison McGeer, MD MSc FRCPC Mount Sinai Hospital/University of Toronto, Toronto, Ontario
Principal Investigator: Deborah Money, MD FRCSC University of British Columbia, Vancouver, British Columbia
Principal Investigator: Graeme N Smith, MD PhD FRCSC Queen's Inversity, Kingston, Ontario
Principal Investigator: Jennifer Blake, MD MSc FRCSC Sunnybrook Health Sciences Centre and Women's College Hospital, University of Toronto
Principal Investigator: Mark Yudin, MD MSc FRCSC St. Michael's Hospital, University of Toronto, Toronto, Ontario
Principal Investigator: Muhammad Mamdani, PharmD MPH Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario
  More Information

No publications provided

Responsible Party: Dr. Shelly McNeil, Principal Investigator, Dalhousie University
ClinicalTrials.gov Identifier: NCT01374009     History of Changes
Other Study ID Numbers: 114141
Study First Received: June 14, 2011
Last Updated: June 14, 2011
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 22, 2014