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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant and postpartum women<br>Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria. | Other: questionnaire<br>* Questionnaire survey<br>|
| healthcare workers<br>Health professionals over 18, working in maternity wards included. | Other: questionnaire<br>* Questionnaire survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify in each maternity hospital facilitators of flu and pertussis vaccination | Qualitative interviews | May 2019 - July 2019 | 
| Proportion of women willing to be vaccinated against pertussis and flu during pregnancy | Questionnaire survey | September 2019-December 2019 | 
| Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis. | Questionnaire survey | October 2019-February 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flu and pertussis immunization coverage of pregnant and postpartum women | Questionnaire survey | September 2019-December 2019 | 
| Flu and pertussis immunization coverage of health professionals | Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services | October 2019-February 2020 | 
| Proportion of patient records with vaccination trace | Review of sample of patient records | October-December 2019 |