NCT04494581

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 22, 2020

Last Update Submit

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.

Other: questionnaire

healthcare workers

Health professionals over 18, working in maternity wards included.

Other: questionnaire

Interventions

Questionnaire survey

Pregnant and postpartum womenhealthcare workers

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Maternité Hôpital Jean Verdier

Bondy, 93143, France

Location

Maternité Notre Dame de Bon Secours - GH Paris St Joseph

Paris, 75014, France

Location

Maternité Port Royal

Paris, 75014, France

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

Locations