COVID-19国际药物怀孕注册表 (COVID-PR):协议考虑因素
Diego F Wyszynski1, Aris T Papageorghiou2, Cheryl Renz3
1Pregistry, London, England. diegow@pregistry.com.
Drug safety
|November 16, 2023
概括
本研究协议概述了COVID-19国际药物怀孕注册表 (COVID-PR),以评估COVID-19治疗在孕妇中的安全性. 它旨在评估特定的COVID-19药物对产科,新生儿和婴儿结果的风险.
科学领域:
- 产科和妇科 产科和妇科
- 药理学 药理学是指药理学的学科.
- 新生儿医学 新生儿医学
背景情况:
- 怀孕期间COVID-19治疗的安全性在很大程度上是未知的.
- 批准用于COVID-19治疗的几种药物缺乏全面的怀孕安全数据.
- 了解治疗安全对于母亲和婴儿健康至关重要.
研究的目的:
- 评估与孕妇COVID-19治疗相关的产科,新生儿和婴儿结局的相对风险.
- 为了比较接受特定COVID-19药物和接受其他治疗的孕妇之间的结果.
- 为怀孕期间管理COVID-19提供基于证据的见解.
主要方法:
- 使用COVID-19国际药物怀孕注册表 (COVID-PR),一个营销后队列研究.
- 与接受COVID-19药物 (单克隆抗体或抗病毒药物) 治疗的孕妇的匹配1:1与对照.
- 在整个怀孕期间和产后12个月内通过在线问卷收集数据.
主要成果:
- 本部分描述的是研究方案,而不是初步结果.
- 该研究旨在评估每个COVID-19药物的安全性.
- 分析特定妊娠期中药物暴露对新生儿结局的影响.
结论:
- "COVID-PR"旨在确定怀孕期间COVID-19药物的安全性.
- 该研究可能会产生关于妊娠期药物暴露和新生儿结果的假设.
- 研究结果将为孕妇COVID-19治疗的临床决策提供信息.
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