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

Vaccine Exposure During Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01374009
• Other study ID #: 114141
• Status: Terminated
• Phase: N/A
• First received: June 14, 2011
• Last updated: January 17, 2017
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2017
• Source: Dalhousie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 504
• Est. completion date: December 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Received the H1N1 vaccine during pregnancy

Exclusion Criteria:

Related Conditions & MeSH terms

• Vaccine Exposure During Pregnancy

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Queen's University	Kingston	Ontario
Canada	Li Ka Shing Knoweldge Institute	Toronto	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	Children's and Women's Health Centre, University of British Columbia	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Dalhousie University	Li Ka Shing Foundation, PHAC/CIHR Influenza Research Network

Country where clinical trial is conducted

Canada,