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Completed

NCT Number: NCT03909126

Pertussis Vaccination in Pregnant Women

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CLSC Montérégie, Longueuil, Quebec, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Boostrix administered during gestational diabetes screening

Biological

Boostrix administered during gestational diabetes screening

Boostrix administered in high volume obstetric clinic

Biological

Boostrix administered in high volume obstetric clinic

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Ministere de la Sante et des Services Sociaux

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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