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

Influenza Vaccination Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05785078
• Other study ID #: 2782
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza Vaccination

Intervention

Behavioral:
• Educational session about vaccinations
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario "A. Gemelli" IRCCS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in knowledge and attitudes regarding vaccination	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.	4 months
Secondary	Vaccination compliance	The impact of the flu vaccination strategy implemented was evaluated through the analysis of compliance to on-site vaccination offer.	4 months