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Evaluation of a Flu Vaccination Program Directed at Pregnant Women Assisted at a Research Hospital in Italy.

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT05785078
Collaborator
(none)
119
Enrollment
1
Location
4
Actual Duration (Months)
29.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Influenza is a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Pregnant women are considered one of the most at-risk groups, as infection can lead to serious complications for the mother and fetus. The Italian Ministry of Health recommends free flu vaccination for pregnant women in the second or third trimester, as the vaccine is safe and effective in protecting the mother, fetus and newborn.

During the 2018-2019 flu season, the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG) held an educational session on maternal and childhood vaccinations in the context of the Childbirth Preparation Course held monthly at the FPG, offering the on-site flu vaccination to participants and their partners, if present.

The objectives of this study are: to improve knowledge and attitudes regarding vaccination in the course participants, assessing their changes through a pre-post anonymous questionnaire; to evaluate the impact of the flu vaccination strategy implemented, through the analysis of vaccination coverage.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational session about vaccinations

Study Design

Study Type:
Observational
Actual Enrollment :
119 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Impact of a Program to Raise Awareness About Flu Vaccination and a Vaccination Campaign Aimed at Women Participating in the Childbirth Preparation Course Held at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Differences in knowledge and attitudes regarding vaccination [4 months]

    The impact of the educational session was evaluated through statistical analysis of the differences between answers to a pre-post questionnaire assessing knowledge and attitudes about vaccination.

Secondary Outcome Measures

  1. Vaccination compliance [4 months]

    The impact of the flu vaccination strategy implemented was evaluated through the analysis of compliance to on-site vaccination offer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Universitario "A. Gemelli" IRCCS Rome RM Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laurenti Patrizia, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05785078
Other Study ID Numbers:
  • 2782
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
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
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Mar 27, 2023