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Moving Forward With Research Involving Pregnant Women: A Critical Role for Wisdom From the Field

机译：与孕妇相关的研究向前发展：实地智慧的关键作用

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Each year, hundreds of thousands of women in the United States confront significant medical illness while pregnant: Hypertension, diabetes, serious psychiatric illnesses, autoimmune diseases such as arthritis and lupus, and even cancers complicate pregnancies. Yet we face a critical dearth of information about how to treat them. Little is known about how drugs work in their bodies, whether those drugs are safe for the fetus, and the extent to which treatment or nontreatment affects maternal and child health (Chambers, Polifka, and Friedman 2008; Fisk and Atun 2008). Recently, a groundswell of attention has begun to highlight the urgent need to garner adequate evidence for the treatment of pregnant women who face illness (Lyerly, Little, and Faden 2008, 2009; Baylis 2010; Macklin 2010). The National Institutes of Health Office of Research on Women’s Health convened a research forum on enrolling pregnant women in research on October 18, 2010 that emphasized both the imperative for and early work on such research1; the Obstetric-Fetal Pharmacology Research Unit (OPRU) Networkand the Microbicide Trials Network have begun to pioneer innovative models for research involving pregnant women.2 The Second Wave Initiative—so named because it calls for a second wave of efforts to follow the legislative and other work of the 1990s promoting fair representation of nonpregnant women in research—has worked to bring together scientists, regulators, and bioethicists to focus attention on the issue.3 All have issued a clarion call: As a matter of health for pregnant women and children, and of justice, we need to finally address what the broader and otherwise successful Women’s Health Initiative left behind—the profound lacuna that is evidence-based treatment during pregnancy.
机译：每年，成千上万的美国妇女在怀孕期间都会面临严重的医疗疾病：高血压，糖尿病，严重的精神疾病，关节炎和狼疮等自身免疫性疾病，甚至癌症也使怀孕复杂化。然而，我们面临着有关如何对待它们的严重缺乏信息。关于药物如何在体内起作用，这些药物对胎儿是否安全以及治疗或不治疗影响母婴健康的程度知之甚少（Chambers，Polifka和Friedman 2008; Fisk和Atun 2008）。近来，注意力开始大量涌现，突出表明迫切需要收集足够的证据来治疗面临疾病的孕妇（Lyerly，Little和Faden，2008年，2009年; Baylis，2010年; Macklin，2010年）。美国国立卫生研究院妇女健康研究办公室于2010年10月18日召开了一个研究论坛，招募孕妇参加研究，强调了此类研究的当务之急和早期工作1。产科-胎儿药理学研究室（OPRU）网络和杀微生物剂试验网络已开始开创创新的研究模式，涉及孕妇。2第二波倡议之所以被命名，是因为它要求第二波努力来遵循立法和其他措施。 1990年代促进非孕妇在研究中的公平代表性的工作–致力于将科学家，监管者和生物伦理学家召集到一起，集中精力解决这个问题。3所有人都发出了号角：作为孕妇和儿童的健康问题，为了正义，我们必须最终解决更广泛而成功的妇女健康倡议所遗留下来的东西-深刻的缺陷，即在怀孕期间进行循证治疗。

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