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The FDA Perspective on the Ethical Barriers of Conducting Research in Pregnant Women

机译:FDA关于孕妇进行研究的伦理障碍的观点

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The need for data related to medication use in pregnancy, especially for psychiatric medications, is undeniable. Onethird of pregnant women are exposed to medication for psychiatric conditions (American College of Obstetricians and Gynecologists 2008). Untreated psychiatric illness during pregnancy may be associated with preterm birth, low birth weight, increased social withdrawal, and reliance on alcohol and drugs. Pregnant women are an understudied population due to the ethical and medical–legal considerations of harming the fetus. Ironically, it is this fear of harming the fetus that often results in lack of data collection in pregnant women and uninformed prescribing without true knowledge of safety or efficacy.
机译:不可否认的是,与怀孕期间使用药物有关的数据特别是精神科药物的需求。三分之一的孕妇因精神疾病而接受药物治疗(美国妇产科学院,2008年)。怀孕期间未经治疗的精神疾病可能与早产,低出生体重,社交退缩增加以及对酒精和药物的依赖有关。由于道德和医学上的法律考虑会伤害胎儿,孕妇是一个未被充分研究的人群。具有讽刺意味的是,这种担心伤害胎儿的恐惧通常会导致孕妇缺乏数据收集,并且在没有真正的安全性或有效性知识的情况下进行不明智的处方。

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