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
2 other identifiers
observational
480
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedJuly 31, 2020
July 1, 2020
11 months
July 22, 2020
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Flu and pertussis immunization coverage of pregnant and postpartum women
September 2019-December 2019
Flu and pertussis immunization coverage of health professionals
October 2019-February 2020
Proportion of patient records with vaccination trace
October-December 2019
Study Arms (2)
Pregnant and postpartum women
Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria.
healthcare workers
Health professionals over 18, working in maternity wards included.
Interventions
Eligibility Criteria
Volunteer women and staff.
You may qualify if:
- 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.
You may not qualify if:
- Women under the protection of a conservator Temporary Health staff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Maternité Hôpital privé
Antony, 92160, France
Maternité Hôpital Jean Verdier
Bondy, 93143, France
Maternité Notre Dame de Bon Secours - GH Paris St Joseph
Paris, 75014, France
Maternité Port Royal
Paris, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 31, 2020
Study Start
May 3, 2019
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
July 31, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share