Pertussis Vaccination in Pregnant Women
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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:

      A detailed costing approach (micro-costing) will be used. Time and movement will be studied
      by direct observation using a grid on an electronic file in each of the 5 environments
      studied in order to identify the services and activities carried out as well as to determine
      the resources involved in the implementation of these services and activities. Three typical
      vaccination days will be chosen to make these observations, in each of the four study
      environments.

      The main activities observed will be related to preparations for vaccination up to the
      vaccination itself (informed consent, injection, etc.), the capture of vaccination data the
      management of vaccines and equipment, clinical manifestations, etc. If necessary, the people
      observed can be interviewed directly to better understand the activities or services
      provided. Otherwise, some questions may be included in the interviews described above.

      The major cost categories that will be evaluated for each of the delivery modalities are
      human resources and supplies. The cost components listed are: nursing time (immunization /
      training), coordination time, support staff time, office supplies, vaccine storage equipment,
      vaccine transportation equipment, vaccine transportation, health and safety equipment,
      emergency, single-use vaccination equipment and others.

      With regard to the costs borne by women, the main categories of variables evaluated will be:
      the time spent making appointments and attending vaccination appointments, working time lost,
      if any, transportation, childcare and other expenses
    

Intervention name(s): Boostrix administered during gestational diabetes screening; Boostrix administered in high volume obstetric clinic
Intervention type(s): Biological; Biological
Intervention description(s): Boostrix administered during gestational diabetes screening; Boostrix administered in high volume obstetric clinic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pertussis; immunization coverage; vaccination; pregnant women; Quebec