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

Pregnant Women Clinical Trial

— GriCoVax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494581
• Other study ID #: GriCoVax - GERES
• Secondary ID: 2019-A00346-51
• Status: Completed
• Start date: May 3, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthcare Worker Patient Transmission
• Influenza Vaccination
• Pertussis Vaccine
• Pregnant Women
• Whooping Cough

Intervention

Other:
• questionnaire
Questionnaire survey

Locations

Country	Name	City	State
France	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

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify in each maternity hospital facilitators of flu and pertussis vaccination	Qualitative interviews	May 2019 - July 2019
Primary	Proportion of women willing to be vaccinated against pertussis and flu during pregnancy	Questionnaire survey	September 2019-December 2019
Primary	Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.	Questionnaire survey	October 2019-February 2020
Secondary	Flu and pertussis immunization coverage of pregnant and postpartum women	Questionnaire survey	September 2019-December 2019
Secondary	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
Secondary	Proportion of patient records with vaccination trace	Review of sample of patient records	October-December 2019