Pertussis Vaccination in Pregnant Women

Study Overview
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Brief Summary
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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
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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

Official Title
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Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation

Conditions
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Pertussis

Intervention / Treatment
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* Biological: Boostrix administered during gestational diabetes screening
* Biological: Boostrix administered in high volume obstetric clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women at least 18 years old who speak English or French Signed Informed Consent Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montreal Region of Quebec<br>Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting | Biological: Boostrix administered during gestational diabetes screening<br>* Boostrix administered during gestational diabetes screening<br>|
| No Intervention: Montérégie<br>Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic | |
| Experimental: Maurice Region<br>Vaccination with Boostrix of pregnant women receiving routine care at high volume clinic | Biological: Boostrix administered in high volume obstetric clinic<br>* Boostrix administered in high volume obstetric clinic<br>|
| No Intervention: National Capital<br>Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pregnant women vaccinated against pertussis | Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions | 11 months, May 2019 o March 2020 | 
| Proportion of pregnant women who consider pertussis as serious risk for infant | Understanding of pertussis risk | 12 months, May 2019 to April 2020 | 
| Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe. | Understanding of vaccine risk perception in pregnant women | 12 months, May 2019 to April 2020 | 
| Costs for each vaccinated woman | The cost of vaccination will be evaluated and compared between the four vaccination models. | 12 months, January to December 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pertussis, immunization coverage, vaccination, pregnant women, Quebec