跳至主要内容
临床试验/NCT01374009
NCT01374009终止不适用

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

Dalhousie University7 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
504
试验地点
7

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Received the H1N1 vaccine during pregnancy

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shelly A. McNeil

MD

Dalhousie University

研究点 (7)

Loading locations...

相似试验

H1N1 Vaccine in Pregnancy: a Registry for the Fall... | 临床试验