Pertussis Vaccination in Pregnant Women

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909126
• Other study ID #: MSSS-PERT-001
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: September 2021
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pregnant women at least 18 years old who speak English or French

• Signed Informed Consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Biological:
• Boostrix administered during gestational diabetes screening
Boostrix administered during gestational diabetes screening
• Boostrix administered in high volume obstetric clinic
Boostrix administered in high volume obstetric clinic

Locations

Country	Name	City	State
Canada	CLSC Montérégie	Longueuil	Quebec
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	CLSC Capitale Nationale	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of pregnant women who consider pertussis as serious risk for infant	Understanding of pertussis risk	12 months, May 2019 to April 2020
Primary	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
Primary	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