Balancing risks: making decisions for maternal treatment without data on fetal safety.
Balancing risks: making decisions for maternal treatment without data on fetal safety.
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DOI：
10.1016/j.ajog.2021.01.025
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发表时间：
2021-05
影响因子：
9.8
通讯作者：
Ecker J
中科院分区：
文献类型：
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作者：
Minkoff H;Ecker J
当改善孕产妇健康的治疗可能给胎儿健康带来风险时，就会出现挑战。 2019 年冠状病毒病 (COVID-19) 疫苗是最新的例子，但并非唯一的例子。由于怀孕患者通常被明确排除在新疗法试验之外，因此这通常是患者和提供者在考虑新疗法时面临的困境。在这项研究中，我们以 COVID-19 疫苗为例来质疑更广泛的问题，即社会，特别是产科医生，应如何平衡孕妇获得新治疗药物的权利的义务与医生保护胎儿免受潜在风险的愿望。我们认为，在几乎所有情况下（除了少数例外，这也将被讨论），孕产妇福利和对自主权的尊重会造成安全数据缺失带来的不确定性。因此，如果孕妇选择尝试新的干预措施和治疗，例如 COVID-19 疫苗接种，则应为她们提供这些新的治疗方案并支持她们的决定。此外，我们认为，避免缺乏数据的困境的正确解决方案是将怀孕个体纳入研究新疗法、药物和其他疗法的临床试验中。我们还将讨论我们观点的基础，即主流产科伦理、法律先例（最高法院裁决禁止公司将女性排除在可能对胎儿构成风险的工作之外）和历史事件（沙利度胺）。伦理框架包括这样的假设：为改善胎儿结局而做出的牺牲是一种美德，而不是一项强制要求。由于怀孕患者生命受到威胁而拒绝接受治疗可能会造成荒谬和自相矛盾的后果。在进行优化孕产妇健康的治疗之前要求堕胎或早产，或者通过延迟治疗来冒着患者自身生命和养育孩子能力的风险，给胎儿和/或新生儿结局带来明显而重大的风险。除了极少数例外，如果不考虑怀孕患者的价值观和目标，就无法在道德上适当地平衡此类后果性行动。因此，怀孕患者和医生需要积极参与共同决策。
Challenges arise when treatment to improve maternal health brings the possibility of risk to fetal health. The coronavirus disease 2019 (COVID-19) vaccine is the most recent, but hardly the only, example. Because pregnant patients are often specifically excluded from trials of new therapies, this is often the dilemma that patients and providers face when considering new treatments. In this study, we used the COVID-19 vaccine as an exemplar to question the broader issue of how society, in general, and obstetricians, in particular, should balance obligations to pregnant women’s right of access to new therapeutic agents with the physician’s desire to protect the fetus from potential risks. We will argue that in almost all circumstances (with few exceptions, as will also be discussed), maternal benefit and respect for autonomy create the uncertainty that absent safety data bring. Consequently, if pregnant women choose to try new interventions and treatments, such as the COVID-19 vaccination, they should be offered those new regimens and their decision supported. In addition, we will argue that the right solution to avoid the dilemma of absent data is to include pregnant individuals in clinical trials studying new treatments, drugs, and other therapies. We will also discuss the basis for our opinion, which are mainstream obstetrical ethics, precedents in law (supreme court ruling that forbids companies to exclude women from jobs that might pose a risk to the fetus), and historic events (thalidomide). The ethical framework includes the supposition that sacrifice to improve fetal outcome is a virtue and not a mandate. Denying a pregnant patient treatment because of threats to their life can create absurd and paradoxical consequences. Either requiring abortion or premature delivery before proceeding with treatments to optimize maternal health, or risking a patient’s own life and ability to parent a child by delaying treatment brings clear and significant risks to fetal and/or neonatal outcomes. With rare exceptions, properly and ethically balancing such consequential actions cannot be undertaken without considering the values and goals of the pregnant patient. Therefore, active participation of both the pregnant patient and their physician in shared decision making is needed.
DOI：
10.15585/mmwr.mm6944e2
发表时间：
2020-11-06
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
Woodworth KR;Olsen EO;Neelam V;Lewis EL;Galang RR;Oduyebo T;Aveni K;Yazdy MM;Harvey E;Longcore ND;Barton J;Fussman C;Siebman S;Lush M;Patrick PH;Halai UA;Valencia-Prado M;Orkis L;Sowunmi S;Schlosser L;Khuwaja S;Read JS;Hall AJ;Meaney-Delman D;Ellington SR;Gilboa SM;Tong VT;CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team;COVID-19 Pregnancy and Infant Linked Outcomes Team (PILOT)
通讯作者：
COVID-19 Pregnancy and Infant Linked Outcomes Team (PILOT)
影响因子：
7.2
作者：
通讯作者：
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影响因子：
7.2
作者：
Minkoff, Howard;Marshall, Mary Faith;Liaschenko, Joan
通讯作者：
Liaschenko, Joan