MedDataX Logo

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

NCT ID: NCT04494581

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-03

Study Completion Date

2020-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pertussis Vaccine Healthcare Worker Patient Transmission Pregnant Women Influenza Vaccination

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant and postpartum women

Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria.

questionnaire

Intervention Type OTHER

Questionnaire survey

healthcare workers

Health professionals over 18, working in maternity wards included.

questionnaire

Intervention Type OTHER

Questionnaire survey

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire

Questionnaire survey

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agence Regionale de Sante d'Ile de France

OTHER_GOV

Sponsor Role collaborator

National Agency of Public Health

OTHER

Sponsor Role collaborator

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

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maternité Hôpital privé

Antony, , France

Site Status

Maternité Hôpital Jean Verdier

Bondy, , France

Site Status

Maternité Notre Dame de Bon Secours - GH Paris St Joseph

Paris, , France

Site Status

Maternité Port Royal

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A00346-51

Identifier Type: OTHER

Identifier Source: secondary_id

GriCoVax - GERES

Identifier Type: -

Identifier Source: org_study_id