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Pertussis Vaccination in Pregnant Women

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03909126
Enrollment
946
Registered
2019-04-09
Start date
2019-06-01
Completion date
2021-05-30
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis

Keywords

pertussis, immunization coverage, vaccination, pregnant women, Quebec

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

Interventions

BIOLOGICALBoostrix administered during gestational diabetes screening

Boostrix administered during gestational diabetes screening

BIOLOGICALBoostrix administered in high volume obstetric clinic

Boostrix administered in high volume obstetric clinic

Sponsors

Ministere de la Sante et des Services Sociaux
CollaboratorOTHER
St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Proportion of pregnant women vaccinated against pertussis11 months, May 2019 o March 2020Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Proportion of pregnant women who consider pertussis as serious risk for infant12 months, May 2019 to April 2020Understanding of pertussis risk
Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.12 months, May 2019 to April 2020Understanding of vaccine risk perception in pregnant women
Costs for each vaccinated woman12 months, January to December 2019The cost of vaccination will be evaluated and compared between the four vaccination models.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026