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

Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04494581
Acronym
GriCoVax
Enrollment
480
Registered
2020-07-31
Start date
2019-05-03
Completion date
2020-03-30
Last updated
2020-07-31

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

Conditions

Healthcare Worker Patient Transmission, Influenza Vaccination, Pertussis Vaccine, Pregnant Women

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.

Interventions

OTHERquestionnaire

Questionnaire survey

Sponsors

Agence Regionale de Sante d'Ile de France
CollaboratorOTHER_GOV
National Agency of Public Health
CollaboratorOTHER
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Identify in each maternity hospital facilitators of flu and pertussis vaccinationMay 2019 - July 2019Qualitative interviews
Proportion of women willing to be vaccinated against pertussis and flu during pregnancySeptember 2019-December 2019Questionnaire survey
Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.October 2019-February 2020Questionnaire survey

Secondary

MeasureTime frameDescription
Flu and pertussis immunization coverage of pregnant and postpartum womenSeptember 2019-December 2019Questionnaire survey
Flu and pertussis immunization coverage of health professionalsOctober 2019-February 2020Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services
Proportion of patient records with vaccination traceOctober-December 2019Review of sample of patient records

Countries

France

Outcome results

None listed

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