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

NCT05785078 | Completed

• 1 other identifier: 2782
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza Vaccination

Outcome Measures

Primary Outcomes (1)

• Differences in knowledge and attitudes regarding vaccination

  Change in Knowledge and Attitudes About Vaccination from Pre- to Post-Educational Session

  4 months

Secondary Outcomes (1)

• Vaccination compliance

  4 months

Interventions

Educational session about vaccinations BEHAVIORAL

An educational session about maternal and childhood vaccinations was held in the context of the Childbirth Preparation Course held monthly at the FPG. In this occasion, on-site flu vaccination was offered to pregnant women attending the course and their partners, if present.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their partners attending the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS

You may qualify if:

• Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS

You may not qualify if:

• None

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: October 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)