疾病预防控制中心COVID-19疫苗怀孕登记:设计,数据收集,反应率和队列描述
Sabrina A Madni1, Andrea J Sharma2, Lauren Head Zauche1
1Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA.
Vaccine
|December 6, 2023
概括
美国疾病预防控制中心 (CDC) 的COVID-19疫苗怀孕注册表 (C19VPR) 监测了孕妇中COVID-19疫苗的安全性. 登记处通过采访和医疗记录收集数据,为这一群体提供了关键的安全信息.
科学领域:
- 公共卫生 公共卫生
- 疫苗学 疫苗学 疫苗学
- 流行病学 流行病学
背景情况:
- 孕妇被排除在最初的COVID-19疫苗试验之外,需要进行特定的安全监测.
- 美国疾病控制和预防中心 (CDC) 建立了CDC COVID-19疫苗怀孕注册表 (C19VPR) 来解决这一数据缺口.
- 监测怀孕期间的疫苗安全性至关重要,因为这种人群中感染的严重结果的风险增加.
研究的目的:
- 描述CDC COVID-19疫苗怀孕注册表 (C19VPR) 的协议,开发和实施.
- 概述数据收集方法,包括参与者采访和医疗记录抽象.
- 报告注册参与者的初始人口统计和疫苗接种情况.
主要方法:
- 疾病预防控制中心C19VPR招募了接种COVID-19疫苗的孕妇或在最后一次月经前30天接种疫苗的孕妇.
- 数据通过电话采访收集,并通过医疗记录审查和临床评估确认/补充.
- 该注册表监测了参与者及其婴儿的健康结果.
主要成果:
- 从2021年1月到6月中旬,确定了123,609名潜在参与者,其中23,339人有资格并注册.
- 超过85%的人同意对自己和/或他们的婴儿进行医疗记录审查.
- 报名参与者主要是非西班牙裔白人 (79.1%),城市居民 (93.3%),30-34岁 (48.3%),89.7%的参与者在怀孕结束时完成了初级疫苗接种.
结论:
- 疾病预防控制中心C19VPR成功收集了孕妇COVID-19疫苗的安全数据.
- 该注册表为未参与初始临床试验的人群提供了必要的安全信息.
- 学习的经验可以为孕妇及其婴儿的未来疫苗安全监测提供信息.
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