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Clinical Trials/NCT01374009
NCT01374009
Terminated
Not Applicable

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

Dalhousie University7 sites in 1 country504 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaccine Exposure During Pregnancy
Sponsor
Dalhousie University
Enrollment
504
Locations
7
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
December 2012
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shelly A. McNeil

MD

Dalhousie University

Eligibility Criteria

Inclusion Criteria

  • Received the H1N1 vaccine during pregnancy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (7)

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