Center of Fetal Medicine and Pregnancy, Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Department of Neurology, Danish Headache Center, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
PLoS One. 2022 Sep 13;17(9):e0271537. doi: 10.1371/journal.pone.0271537. eCollection 2022.
Paracetamol (N-acetyl-p-aminophenol (APAP), also known as acetaminophen) is used to relieve mild to moderate pain and reduce fever. APAP is widely used during pregnancy as it is considered safe when used as directed by regulatory authorities. However, a significant amount of epidemiological and experimental research suggests that prenatal exposure potentially alters fetal development. In this paper, we summarize the potentially harmful adverse effects of APAP and the limitations of the current evidence. It highlights the urgent need for a clinical trial, and the aim of the presented qualitative pilot study on APAP use during pregnancy is the feasibility of a large-scale randomized controlled trial (RCT). In the qualitative study, we included 232 Danish women from three hospitals in the spring of 2021. After recognizing the pregnancy, 48% had taken any APAP, and 6% had taken it weekly or more than weekly. A total of 27% who had taken APAP in the first trimester of pregnancy (even rarely) would potentially participate in an RCT. In a potential clinical trial, the women would need to be included early in the 1st trimester as the suspected harmful effects of APAP lies within this early reproductive developmental window. A possible recruitment strategy was explored. These data suggest that the target population appears positive towards an RCT. As a negative attitude among users has been considered the major hindrance for such a study, we cannot see hindrances for performing an RCT.
对乙酰氨基酚（N-乙酰对氨基酚（APAP），也称为扑热息痛）用于缓解轻度至中度疼痛和降低体温。APAP 在怀孕期间被广泛使用，因为监管机构认为在规定的用法和剂量下使用是安全的。然而，大量的流行病学和实验研究表明，产前暴露可能会改变胎儿的发育。在本文中，我们总结了 APAP 可能产生的有害不良影响以及当前证据的局限性。它强调了进行临床试验的迫切需要，并且提出的关于怀孕期间使用 APAP 的定性先导研究的目的是进行大规模随机对照试验（RCT）的可行性。在定性研究中，我们纳入了 2021 年春季来自三家丹麦医院的 232 名女性。在确认怀孕后，48%的人服用过任何 APAP，6%的人每周或每周以上服用。在怀孕的第一个三个月内偶尔服用过 APAP 的 27%的人可能会参加 RCT。在潜在的临床试验中，需要在妊娠的第 1 个月尽早纳入女性，因为 APAP 的可疑有害影响存在于这一早期生殖发育窗口内。我们探讨了一种可能的招募策略。这些数据表明，目标人群对 RCT 持积极态度。由于使用者的消极态度被认为是进行此类研究的主要障碍，因此我们认为进行 RCT 不存在障碍。
