Clinical trial NCT04494581: GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region
Official title: Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis Vaccine
Healthcare Worker Patient Transmission
Pregnant Women
Influenza Vaccination
Lead sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Sponsor class: NETWORK
Collaborators: name: Agence Regionale de Sante d'Ile de France
name: National Agency of Public Health
First posted: 2020-07-31
Enrollment: 480
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer women and staff.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify in each maternity hospital facilitators of flu and pertussis vaccination
timeFrame: May 2019 - July 2019
measure: Proportion of women willing to be vaccinated against pertussis and flu during pregnancy
timeFrame: September 2019-December 2019
measure: Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
timeFrame: October 2019-February 2020
Secondary outcomes:
measure: Flu and pertussis immunization coverage of pregnant and postpartum women
timeFrame: September 2019-December 2019
measure: Flu and pertussis immunization coverage of health professionals
timeFrame: October 2019-February 2020
measure: Proportion of patient records with vaccination trace
timeFrame: October-December 2019
Other outcomes:
Locations:
city: Antony
country: France
facility: Maternité Hôpital privé
city: Bondy
country: France
facility: Maternité Hôpital Jean Verdier
city: Paris
country: France
facility: Maternité Notre Dame de Bon Secours - GH Paris St Joseph
city: Paris
country: France
facility: Maternité Port Royal
Study officials:
References: