CClinicalTrials.gg
CompletedNCT05785078Updated Aug 14, 2025

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

An observational study in Influenza Vaccination, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
119
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza Vaccination

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 119 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

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Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
119 participants (actual)
Patient registry
No

Interventions

  • BehavioralEducational 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.

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What researchers measure

Primary outcomes

  1. Differences in knowledge and attitudes regarding vaccination

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

    Time frame: 4 months

Secondary outcomes

  1. Vaccination compliance

    Number of Participants Compliant with On-site Influenza Vaccination Offer

    Time frame: 4 months

07

Study locations

1 site
  • Fondazione Policlinico Universitario "A. Gemelli" IRCCS
    Rome, RM 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05785078
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Laurenti Patrizia (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 27, 2023
Start date
Oct 1, 2019
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
Aug 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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