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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnant Women; Influenza Vaccination; Pertussis Vaccine; Healthcare Worker Patient Transmission
• Intervention / Treatment: Other: questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• France
  • Antony, France, 92160
    • Maternité Hôpital privé
  • Bondy, France, 93143
    • Maternité Hôpital Jean Verdier
  • Paris, France, 75014
    • Maternité Notre Dame de Bon Secours - GH Paris St Joseph
  • Paris, France, 75014
    • Maternité Port Royal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteer women and staff.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant and postpartum women; Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria.	Other: questionnaire; Questionnaire survey
healthcare workers; Health professionals over 18, working in maternity wards included.	Other: questionnaire; Questionnaire survey

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Collaborators: Agence Regionale de Sante d'Ile de France; National Agency of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: GriCoVax - GERES; 2019-A00346-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No