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Pertussis Vaccination in Pregnant Women

Primary Purpose

Pertussis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Boostrix administered during gestational diabetes screening
Boostrix administered in high volume obstetric clinic
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis focused on measuring pertussis, immunization coverage, vaccination, pregnant women, Quebec

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • CLSC Montérégie
  • CHU Sainte-Justine
  • CLSC Capitale Nationale

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Montreal Region of Quebec

Montérégie

Maurice Region

National Capital

Arm Description

Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting

Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic

Vaccination with Boostrix of pregnant women receiving routine care at high volume clinic

Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic

Outcomes

Primary Outcome Measures

Proportion of pregnant women vaccinated against pertussis
Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Proportion of pregnant women who consider pertussis as serious risk for infant
Understanding of pertussis risk
Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.
Understanding of vaccine risk perception in pregnant women
Costs for each vaccinated woman
The cost of vaccination will be evaluated and compared between the four vaccination models.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2018
Last Updated
September 22, 2021
Sponsor
St. Justine's Hospital
Collaborators
Ministere de la Sante et des Services Sociaux
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1. Study Identification

Unique Protocol Identification Number
NCT03909126
Brief Title
Pertussis Vaccination in Pregnant Women
Official Title
Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Ministere de la Sante et des Services Sociaux

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
pertussis, immunization coverage, vaccination, pregnant women, Quebec

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
946 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montreal Region of Quebec
Arm Type
Experimental
Arm Description
Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting
Arm Title
Montérégie
Arm Type
No Intervention
Arm Description
Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic
Arm Title
Maurice Region
Arm Type
Experimental
Arm Description
Vaccination with Boostrix of pregnant women receiving routine care at high volume clinic
Arm Title
National Capital
Arm Type
No Intervention
Arm Description
Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic
Intervention Type
Biological
Intervention Name(s)
Boostrix administered during gestational diabetes screening
Intervention Description
Boostrix administered during gestational diabetes screening
Intervention Type
Biological
Intervention Name(s)
Boostrix administered in high volume obstetric clinic
Intervention Description
Boostrix administered in high volume obstetric clinic
Primary Outcome Measure Information:
Title
Proportion of pregnant women vaccinated against pertussis
Description
Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Time Frame
11 months, May 2019 o March 2020
Title
Proportion of pregnant women who consider pertussis as serious risk for infant
Description
Understanding of pertussis risk
Time Frame
12 months, May 2019 to April 2020
Title
Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.
Description
Understanding of vaccine risk perception in pregnant women
Time Frame
12 months, May 2019 to April 2020
Title
Costs for each vaccinated woman
Description
The cost of vaccination will be evaluated and compared between the four vaccination models.
Time Frame
12 months, January to December 2019

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women at least 18 years old who speak English or French Signed Informed Consent Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Quach, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CLSC Montérégie
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
CLSC Capitale Nationale
City
Québec
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Pertussis Vaccination in Pregnant Women

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