Pertussis Vaccination in Pregnant Women

• ClinicalTrials.gov Identifier: NCT03909126
• Recruitment Status: Completed
• First Posted: April 9, 2019
• Last Update Posted: September 24, 2021
• Sponsor: St. Justine's Hospital
• Collaborator: Ministere de la Sante et des Services Sociaux
• Information provided by (Responsible Party): Caroline Quach, MD, St. Justine's Hospital

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.

Condition or disease	Intervention/treatment	Phase
Pertussis	Biological: Boostrix administered during gestational diabetes screening; Biological: Boostrix administered in high volume obstetric clinic	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 946 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
• Actual Study Start Date: June 1, 2019
• Actual Primary Completion Date: May 30, 2021
• Actual Study Completion Date: May 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: pregnant females
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Locations

Canada, Quebec

CLSC Montérégie

Longueuil, Quebec, Canada

CHU Sainte-Justine

Montréal, Quebec, Canada, H3T 1C5

CLSC Capitale Nationale

Québec, Quebec, Canada

Sponsors and Collaborators

St. Justine's Hospital

Ministere de la Sante et des Services Sociaux

Investigators

• Principal Investigator: Caroline Quach, MD; St. Justine's Hospital

More Information

• Responsible Party: Caroline Quach, MD, Medical Lead Infection Prevention and Control, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT03909126
• Other Study ID Numbers: MSSS-PERT-001
• First Posted: April 9, 2019
• Last Update Posted: September 24, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Caroline Quach, MD, St. Justine's Hospital:

pertussis; immunization coverage; vaccination; pregnant women; Quebec

Additional relevant MeSH terms:

Whooping Cough; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases