Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 946
- 试验地点
- 3
- 主要终点
- Proportion of pregnant women who consider pertussis as serious risk for infant
研究概览
简要总结
Brief Summary: The study compares four models of pertussis vaccination dispensation to pregnant women on the vaccine coverage obtained. In addition, the cost of the different models of vaccination will be evaluated.
详细描述
This is a quasi-experimental study with a non-equivalent control group in pregnant women, taking place in 4 regions of Québec (Montréal, Montérégie, Capitale-Nationale, Mauricie). Four models of vaccine dispensation will be evaluated: one university hospital around gestational diabetes screening, local health and social services centres (CSLC) and a high volume clinic. 250 participants will be recruited in each of the four types of centres.
In addition, the study will also evaluate the costs incurred by all those involved in the pertussis vaccination program for pregnant women as well as the cost per woman vaccinated.
Health Professionals:
15 to 20 health professionals involved in providing immunization services to pregnant women: obsterician-gynaecologists, family doctors and nurses in participating clinics will be interviewed to evaluate their knowledge, attitudes and professional practises regarding pertussis vaccination during pregnancy.
Evaluating the Cost:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women at least 18 years old who speak English or French
- •Signed Informed Consent
排除标准
- 未提供
研究组 & 干预措施
National Capital
Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic
Montreal Region of Quebec
Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting
干预措施: Boostrix administered during gestational diabetes screening (Biological)
Montérégie
Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic
Maurice Region
Vaccination with Boostrix of pregnant women receiving routine care at high volume clinic
干预措施: Boostrix administered in high volume obstetric clinic (Biological)
结局指标
主要结局
Proportion of pregnant women who consider pertussis as serious risk for infant
时间窗: 12 months, May 2019 to April 2020
Understanding of pertussis risk
Proportion of pregnant women vaccinated against pertussis
时间窗: 11 months, May 2019 o March 2020
Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.
时间窗: 12 months, May 2019 to April 2020
Understanding of vaccine risk perception in pregnant women
Costs for each vaccinated woman
时间窗: 12 months, January to December 2019
The cost of vaccination will be evaluated and compared between the four vaccination models.
次要结局
未报告次要终点
研究者
Caroline Quach, MD
Medical Lead Infection Prevention and Control
St. Justine's Hospital