Pertussis Vaccination in Pregnant Women

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis
• Intervention / Treatment: Biological: Boostrix administered during gestational diabetes screening; Biological: Boostrix administered in high volume obstetric clinic

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

• Study Type: Interventional
• Enrollment (Actual): 946
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Longueuil, Quebec, Canada
      • CLSC Montérégie
    • Montréal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine
    • Québec, Quebec, Canada
      • CLSC Capitale Nationale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Ministere de la Sante et des Services Sociaux
• Investigators: Principal Investigator: Caroline Quach, MD, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: pregnant women; vaccination; pertussis; immunization coverage; Quebec
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: MSSS-PERT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No