Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Pregistry, California, Los Angeles, USA.
Birth Defects Res. 2022 Sep 1;114(15):906-914. doi: 10.1002/bdr2.2070. Epub 2022 Aug 5.
There is limited information about the effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the first trimester of pregnancy on the risk of major congenital malformations (MCMs). The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) was designed to estimate the relative risk of adverse perinatal outcomes among women with Coronavirus Disease 2019 (COVID-19) at specific times during gestation. Adult women were eligible to enroll if they had a SARS-CoV-2 test, regardless of the results, or clinically confirmed COVID-19 during pregnancy. Self-administered questionnaires collected data on SARS-CoV-2 infection, pregnancy outcomes (including detailed questions on MCMs), and potential confounders. The analysis of MCMs includes women with either a positive SARS-CoV-2 PCR test or a clinical diagnosis of COVID-19 during the first trimester (exposed group) or a negative SARS-CoV-2 test (reference) that enrolled while pregnant. Sensitivity analyses were restricted to participants who enrolled before the availability of informative prenatal screening tests and extended to those enrolled after end of pregnancy. Generalized linear models were used to estimate relative risks (RR) and 95% confidence intervals (CI). Of 17,163 participants enrolled between June 2020 and July 2021, 1727 had a SARS-CoV-2 infection during the first trimester, of whom 1,675 enrolled during pregnancy. Of 10,235 controls with a negative test during pregnancy, 4,172 enrolled during pregnancy. Restriction to participants with complete follow-up reduced the sample size to 92 exposed and 292 unexposed reference pregnancies. MCMs were reported in 3 (3.3%) exposed and 8 (2.7%) unexposed (RR 1.2; 95% CI 0.32-4.2) newborns. The RR was 2.5 (95%CI 0.23-27) among those enrolled before prenatal screening, and 2.2 (95%CI 0.89-5.3) in the overall study population including those enrolled post-pregnancy. No specific pattern of malformations was observed. Although results are compatible with no major teratogenic effects associated with maternal SARS-CoV-2 infection, RR estimates were imprecise and larger studies are warranted.
关于严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染在妊娠早期对主要先天性畸形（MCM）风险的影响，信息有限。国际妊娠冠状病毒暴露登记处（IRCEP）旨在估计在特定妊娠时间点患有 2019 年冠状病毒病（COVID-19）的女性不良围产期结局的相对风险。如果成年女性在怀孕期间进行了 SARS-CoV-2 检测，无论结果如何，或临床确诊 COVID-19，均可有资格参加登记。自我管理的问卷调查收集了 SARS-CoV-2 感染、妊娠结局（包括 MCM 的详细问题）和潜在混杂因素的数据。MCM 的分析包括在妊娠早期 SARS-CoV-2 PCR 检测阳性或临床诊断为 COVID-19 的女性（暴露组）或 SARS-CoV-2 检测阴性的女性（参考组）。敏感性分析仅限于在可获得信息性产前筛查试验之前参加的参与者，并扩展到妊娠结束后参加的参与者。广义线性模型用于估计相对风险（RR）和 95%置信区间（CI）。在 2020 年 6 月至 2021 年 7 月期间登记的 17163 名参与者中，有 1727 名在妊娠早期感染了 SARS-CoV-2，其中 1675 名在妊娠期间登记。在 10235 名妊娠期间 SARS-CoV-2 检测阴性的对照组中，有 4172 名在妊娠期间登记。限制在有完整随访的参与者中，将样本量减少到 92 名暴露和 292 名未暴露的参考妊娠。在 3 名（3.3%）暴露和 8 名（2.7%）未暴露的新生儿中报告了 MCM（RR 1.2；95%CI 0.32-4.2）。在接受产前筛查之前登记的参与者中，RR 为 2.5（95%CI 0.23-27），在包括妊娠后登记的所有参与者中，RR 为 2.2（95%CI 0.89-5.3）。未观察到特定的畸形模式。尽管结果表明与母亲 SARS-CoV-2 感染相关的主要致畸作用不大，但 RR 估计值不够精确，需要更大规模的研究。
