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Completed

NCT Number: NCT04494581

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

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.

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Key information

Conditions

Pertussis Vaccine Healthcare Worker Patient Transmission Infections Influenza Vaccination Influenza, Human Orthomyxoviridae Infections Pregnant Women RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternité Hôpital privé, Antony, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Questionnaire survey

Primary outcomes

  1. Identify in each maternity hospital facilitators of flu and pertussis vaccination

    Time frame: May 2019 - July 2019

    Qualitative interviews

  2. Proportion of women willing to be vaccinated against pertussis and flu during pregnancy

    Time frame: September 2019-December 2019

    Questionnaire survey

  3. Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.

    Time frame: October 2019-February 2020

    Questionnaire survey

Secondary outcomes

  1. Flu and pertussis immunization coverage of pregnant and postpartum women

    Time frame: September 2019-December 2019

    Questionnaire survey

  2. Flu and pertussis immunization coverage of health professionals

    Time frame: 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

    Time frame: October-December 2019

    Review of sample of patient records

Sponsors and collaborators

Lead sponsor

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Network

Collaborators

  • Agence Regionale de Sante d'Ile de France
  • National Agency of Public Health

Registry information

Official study title

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

Acronym: GriCoVax

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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