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

NCT05729191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-02-16

No results posted yet for this study

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

Interventions

BIOLOGICAL

Anti Covid 19 vaccination campaign for pregnat women

Assessment of vaccine hesitancy and Covid-19 disease knowledge

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Stefania Bruno, edicine · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729191 on ClinicalTrials.gov