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

Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux (Other)
Overall Status
Completed
CT.gov ID
NCT04494581
Collaborator
Agence Regionale de Sante d'Ile de France (Other), National Agency of Public Health (Other)
480
4
10.9
120
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
480 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals
Actual Study Start Date :
May 3, 2019
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Identify in each maternity hospital facilitators of flu and pertussis vaccination [May 2019 - July 2019]

    Qualitative interviews

  2. Proportion of women willing to be vaccinated against pertussis and flu during pregnancy [September 2019-December 2019]

    Questionnaire survey

  3. Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis. [October 2019-February 2020]

    Questionnaire survey

Secondary Outcome Measures

  1. Flu and pertussis immunization coverage of pregnant and postpartum women [September 2019-December 2019]

    Questionnaire survey

  2. Flu and pertussis immunization coverage of health professionals [October 2019-February 2020]

    Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services

  3. Proportion of patient records with vaccination trace [October-December 2019]

    Review of sample of patient records

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternité Hôpital privé Antony France 92160
2 Maternité Hôpital Jean Verdier Bondy France 93143
3 Maternité Notre Dame de Bon Secours - GH Paris St Joseph Paris France 75014
4 Maternité Port Royal Paris France 75014

Sponsors and Collaborators

  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
ClinicalTrials.gov Identifier:
NCT04494581
Other Study ID Numbers:
  • GriCoVax - GERES
  • 2019-A00346-51
First Posted:
Jul 31, 2020
Last Update Posted:
Jul 31, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2020