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Pertussis Vaccination in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909126
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Caroline Quach, MD, St. Justine's Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1240 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2021


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



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.



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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909126


Contacts
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Contact: Zineb Laghdir, MSc +1 514 345 4931 zineb.laghdir@recherche-ste-justine.qc.ca
Contact: Caroline Quach, MD +1 514 345 4931 ext 7430 c.quach@umontreal.ca

Locations
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Canada, Quebec
CLSC Montérégie Recruiting
Longueuil, Quebec, Canada
Contact: Maryse Guay, MD    450-928-6777 ext 3070      
CHU Sainte-Justine Completed
Montréal, Quebec, Canada, H3T 1C5
CLSC Capitale Nationale Recruiting
Québec, Quebec, Canada
Contact: Nicholas Brousseau, MD    418-666-7000 ext 309      
Sponsors and Collaborators
St. Justine's Hospital
Ministere de la Sante et des Services Sociaux
Investigators
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Principal Investigator: Caroline Quach, MD St. Justine's Hospital
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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    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases