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临床试验/NCT05729191
NCT05729191已完成不适用

Evaluation of the Acceptance of the Anti-COVID-19 Vaccine Offer and of the Knowledge and Attitudes Towards the Vaccination Among Pregnant Women Through a Validation Study at the Fondazione Policlinico Universitario A IRCCS Twins (FPG).

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Compliance and knowledge

研究概览

简要总结

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.

详细描述

Background 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 the extension of the vaccination offer, with mRNA vaccines, to all pregnant women in the second and third trimester. Although vaccination can be considered throughout pregnancy, a benefit-risk assessment with a physician is recommended for women wishing to be vaccinated in the first trimester, as there is still little evidence relating to this gestational age. Finally, the same document identifies the priority target for vaccination in pregnancy:

  • women at increased risk of contracting SARS-CoV-2 infection (e.g. health professionals, caregivers)
  • and/or at greater risk of developing a serious disease from COVID-19 (women with risk factors: age >30 years, BMI >30, comorbidities, citizenship of countries with high migratory pressure), with possible repercussions also on the outcomes fetus/ neonates.

Project phases

The study includes six implementation phases:

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Pregnant women under 18 years old

结局指标

主要结局

Compliance and knowledge

时间窗: 2021-2022

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Stefania

Medical Doctor Specialized In Hygiene and Preventive Medicine, Researcher

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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