Evaluation of the Acceptance of the Anti-COVID-19 Vaccine Offer Among Pregnant Women

NCT05729191 | Completed

• 1 other identifier: 4557
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The SARS-CoV-2 pandemic still represents a global health, social and economic emergency. In Italy, since the beginning of the pandemic, a total of 4,709,753 cases and 131,461 deaths have been recorded. The vaccination campaign against COVID-19, launched on 27 December 2020, has made it possible in Italy to achieve complete vaccination coverage (two doses) of 80.6% of the population aged \> 12 years. The latest data on the impact of vaccination in preventing new infections, hospitalizations and deaths report a strong reduction in the risk of SARS-CoV-2 infection in fully vaccinated people compared to unvaccinated people (78% for diagnosis, 92% for hospitalization, 95% for ICU admissions and 94% for deaths); most of the cases notified in the last 30 days in Italy have been diagnosed in unvaccinated people2. Evidence on the immunogenicity and safety of anti-SARS-CoV-2 vaccination in pregnant women, although not deriving from clinical trials, is growing, even if not yet conclusive. On the efficacy of mRNA vaccines in pregnancy, a retrospective Israeli cohort study reported a significantly lower risk of contracting SARS-CoV-2 infection compared to unvaccinated women. Furthermore, a greater maternal and perinatal morbidity from COVID-19, also associated with the circulation of the Delta variant, has been highlighted by the recent analyzes of the English data, updated to 11 July 2021. The Istituto Superiore di Sanità, in the light of the growing evidence on the safety of vaccination during pregnancy for both the fetus and the mother, the new evidence relating to the greater morbidity associated with the Delta variant, the growing circulation of the same variant and the significant lowering of median age at infection in Italy, recommends extending the vaccine offer, with mRNA vaccines, to all pregnant women in the second and third trimester. Objectives of the study: Evaluate the quality in terms of reception of the anti-COVID-19 vaccine offer, the knowledge and attitudes towards the aforementioned vaccination by pregnant women who join the Vaccination Open Day and who access the FPG Covid Vaccination Center for this vaccination. Primary endpoint: Measuring acceptance of the anti-COVID-19 vaccine offer and knowledge about vaccination, by means of a questionnaire to be administered after vaccination.

Conditions

Pregnant Women; COVID 19 Vaccine; Vaccination Hesitancy

Outcome Measures

Primary Outcomes (1)

• Compliance and knowledge

  Measure the acceptance of the anti-COVID-19 vaccine offer and knowledge about vaccination, by means of a questionnaire to be administered after vaccination.

  2021-2022

Interventions

Anti Covid 19 vaccination campaign for pregnat women BIOLOGICAL

Assessment of vaccine hesitancy and Covid-19 disease knowledge

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The population included in the study is represented by pregnant women who will join the vaccination offer, recruited from those enrolled in the childbirth preparation course, organized by the UOC of Obstetrics and Obstetric Pathology of the FPG and/or belonging to the Covid FPG Vaccination Center.

You may qualify if:

• The population included in the study is represented by pregnant women who will join the vaccination offer, recruited from those enrolled in the childbirth preparation course, organized by the UOC of Obstetrics and Obstetric Pathology of the FPG and/or belonging to the Covid FPG Vaccination Center.

You may not qualify if:

• \- Pregnant women under 18 years old

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stefania Bruno, edicine

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Specialized In Hygiene and Preventive Medicine, Researcher

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 15, 2023
• Study Start: October 25, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)