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GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region

Completed
Conditions
Pregnant Women
Healthcare Worker Patient Transmission
Influenza Vaccination
Pertussis Vaccine
Interventions
Other: questionnaire
Registration Number
NCT04494581
Lead Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Brief Summary

Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.

Detailed Description

Multicentre, descriptive study conducted in a declarative manner and supplemented by direct observation by an investigator.

Main objectives:

* Assess existing practices of the various actors involved in flu and pertussis vaccination of pregnant or postpartum women medically followed in maternity wards.

* Assess acceptability of pertussis and flu vaccination during pregnancy by women medically followed in maternity wards, and by health professionals of theses facilities.

Secondary objectives:

* Assess flu and pertussis immunization coverage of pregnant and postpartum women and of health professionals working in maternity wards.

* Assess the links between immunization coverage of health professionals and their current practices in promoting flu and pertussis vaccination of women in maternity wards.

Main outcome measures:

* Identify in each maternity hospital facilitators of flu and pertussis vaccination.

* Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.

* Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.

Secondary endpoints:

* Flu and pertussis immunization coverage of pregnant and postpartum women.

* Flu and pertussis immunization coverage of health professionals.

* Proportion of patient records with vaccination trace.

* Link between understanding of vaccines and vaccine-preventable diseases, and immunization coverage of health professionals.

* Link between attitudes and practices of health professionals, and immunization coverage of patients.

* Link between immunization coverage of patients and health professionals.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
480
Inclusion Criteria

Pregnant and postpartum women over 18 medically followed in maternity wards included. Femmes enceintes ou en post-partum :

Health professionals over 18 working in maternity wards included.

Exclusion Criteria

Women under the protection of a conservator Temporary Health staff

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
healthcare workersquestionnaireHealth professionals over 18, working in maternity wards included.
Pregnant and postpartum womenquestionnairePregnant and postpartum women over 18, meeting inclusion and exclusion criteria.
Primary Outcome Measures
NameTimeMethod
Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.October 2019-February 2020

Questionnaire survey

Identify in each maternity hospital facilitators of flu and pertussis vaccinationMay 2019 - July 2019

Qualitative interviews

Proportion of women willing to be vaccinated against pertussis and flu during pregnancySeptember 2019-December 2019

Questionnaire survey

Secondary Outcome Measures
NameTimeMethod
Proportion of patient records with vaccination traceOctober-December 2019

Review of sample of patient records

Flu and pertussis immunization coverage of pregnant and postpartum womenSeptember 2019-December 2019

Questionnaire survey

Flu and pertussis immunization coverage of health professionalsOctober 2019-February 2020

Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services

Trial Locations

Locations (4)

Maternité Hôpital privé

🇫🇷

Antony, France

Maternité Hôpital Jean Verdier

🇫🇷

Bondy, France

Maternité Notre Dame de Bon Secours - GH Paris St Joseph

🇫🇷

Paris, France

Maternité Port Royal

🇫🇷

Paris, France

Maternité Hôpital privé
🇫🇷Antony, France
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