Objectives To evaluate the risk of major congenital anomalies according to infection with or vaccination against covid-19 during the first trimester of pregnancy. Design Prospective Nordic registry based study. Setting Sweden, Denmark, and Norway. Participants 343 066 liveborn singleton infants in Sweden, Denmark, and Norway, with an estimated start of pregnancy between 1 March 2020 and 14 February 2022, identified using national health registries. Main outcome measure Major congenital anomalies were categorised using EUROCAT (European Surveillance of Congenital Anomalies) definitions. The risk after covid-19 infection or vaccination during the first trimester was assessed by logistic regression, adjusting for maternal age, parity, education, income, country of origin, smoking, body mass index, chronic conditions, and estimated date of start of pregnancy. Results 17 704 (5.2%) infants had a major congenital anomaly. When evaluating risk associated with covid-19 infection during the first trimester, the adjusted odds ratio ranged from 0.84 (95% confidence interval 0.51 to 1.40) for eye anomalies to 1.12 (0.68 to 1.84) for oro-facial clefts. Similarly, the risk associated with covid-19 vaccination during the first trimester ranged from 0.84 (0.31 to 2.31) for nervous system anomalies to 1.69 (0.76 to 3.78) for abdominal wall defects. Estimates for 10 of 11 subgroups of anomalies were less than 1.04, indicating no notable increased risk. Conclusions Covid-19 infection and vaccination during the first trimester of pregnancy were not associated with risk of congenital anomalies. The data used in this study are available through application to Pregnancy Register (Datauttag | Graviditetsregistret, [medscinet.com][1]), National Board of Health and Welfare () and Statistics Sweden () in Sweden; Statistics Denmark (), the Danish Health Data Authorities ([https://sundhedsdatastyrelsen.dk/da/forskerservice/om-forskerservice/nyheder\_forskerservice/vaccinedata\_031023][2]), and Statens Serum Institute () in Denmark; and the Norwegian Institute of Public Health in Norway ([helsedata.no/en/][3]). The analysis scripts are available upon request to the corresponding author. [1]: file:///%5C%5C%5C%5Cbmauk.net%5C%5Cbmj%5C%5CEditorIal%5C%5C_content_processing%5C%5Ccontent_store%5C%5Cbmj%5C%5Carticles%5C%5Cresearch%5C%5Cmagm079364%5C%5Cwip%5C%5Cmedscinet.com [2]: https://sundhedsdatastyrelsen.dk/da/forskerservice/om-forskerservice/nyheder_forskerservice/vaccinedata_031023 [3]: http://helsedata.no/en/

中文翻译：

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妊娠早期 Covid-19 感染和疫苗接种以及先天性异常的风险：基于北欧登记的研究


目的 根据怀孕前三个月感染或接种 covid-19 疫苗来评估主要先天性异常的风险。设计基于北欧登记的前瞻性研究。设置瑞典、丹麦和挪威。参与者包括瑞典、丹麦和挪威的 343 066 名活产单胎婴儿，根据国家卫生登记处确定，预计开始怀孕时间为 2020 年 3 月 1 日至 2022 年 2 月 14 日。主要结果指标 使用 EUROCAT（欧洲先天性异常监测）定义对主要先天性异常进行分类。通过逻辑回归评估孕早期感染 covid-19 或接种疫苗后的风险，并根据母亲年龄、胎次、教育程度、收入、原籍国、吸烟、体重指数、慢性病和预计怀孕开始日期进行调整。结果 17 704 名（5.2%）婴儿患有严重先天性异常。在评估妊娠早期与 covid-19 感染相关的风险时，调整后的比值比范围为眼睛异常的 0.84（95% 置信区间 0.51 至 1.40）到口颌面裂的 1.12（0.68 至 1.84）。同样，妊娠前三个月与 covid-19 疫苗接种相关的风险范围从神经系统异常的 0.84（0.31 至 2.31）到腹壁缺陷的 1.69（0.76 至 3.78）。 11 个异常亚组中有 10 个的估计值低于 1.04，表明风险没有显着增加。结论 怀孕前三个月的 Covid-19 感染和疫苗接种与先天性异常的风险无关。本研究中使用的数据可通过向妊娠登记处申请获得（Datauttag | Graviditetsregistret，[medscinet.com][1]）、瑞典国家卫生和福利委员会 () 和瑞典统计局 ()；丹麦统计局 ()、丹麦健康数据机构 ([https://sundhedsdatastyrelsen.dk/da/forskerservice/om-forskerservice/nyheder\_forskerservice/vaccinedata\_031023][2]) 和丹麦 Statens 血清研究所 ()；和挪威公共卫生研究所 ([helsedata.no/en/][3])。分析脚本可根据相应作者的要求提供。 [1]: 文件:///%5C%5C%5C%5Cbmauk.net%5C%5Cbmj%5C%5CEditorIal%5C%5C_content_processing%5C%5Ccontent_store%5C%5Cbmj%5C%5Carticles%5C%5Cresearch%5C% 5Cmagm079364%5C%5Cwip%5C%5Cmedscinet.com [2]：https://sundhedsdatastyrelsen.dk/da/forskerservice/om-forskerservice/nyheder_forskerservice/vaccinedata_031023 [3]：http://helsedata。否/en/