A prospective cohort study of preconception COVID-19 vaccination and miscarriage.
A prospective cohort study of preconception COVID-19 vaccination and miscarriage.
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一项关于孕前 COVID-19 疫苗接种和流产的前瞻性队列研究。
DOI：
10.1093/humrep/dead211
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Wise,LaurenA
中科院分区：
文献类型：
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作者：
Yland,JenniferJ;Wesselink,AmeliaK;Regan,AnnetteK;Hatch,ElizabethE;Rothman,KennethJ;Savitz,DavidA;Wang,TanranR;Huybrechts,KristaF;Hernández-Díaz,Sonia;Eisenberg,MichaelL;Wise,LaurenA
研究问题 孕前母体或父体冠状病毒病 2019 (COVID-19) 疫苗接种在多大程度上与流产发生率相关？摘要回答 受孕前任何时间伴侣接种 COVID-19 疫苗与流产率增加无关。已知信息 几项观察性研究评估了怀孕期间接种 COVID-19 疫苗的安全性，发现与流产无关，尽管没有前瞻性研究评估了与 COVID-19 疫苗接种相关的早期流产（妊娠周 [GW] <8）的风险。此外，还没有研究评估孕前疫苗接种对男性和女性伴侣的作用。研究设计、规模、持续时间一项基于互联网的前瞻性孕前队列研究，对象为居住在美国和加拿大的夫妇。我们分析了 2020 年 12 月至 2022 年 11 月期间怀孕的 1815 名女性参与者的数据，其中包括 1570 对有男性伴侣疫苗接种数据的夫妇。 参与者/材料、环境、方法符合条件的女性参与者年龄为 21-45 岁，并且在入组时试图在不使用生育治疗的情况下怀孕。女性参与者在基线、怀孕前每 8 周以及怀孕早期和晚期完成问卷调查；她们还可以邀请男性伴侣填写基线调查问卷。我们在所有问卷中收集了有关 COVID-19 疫苗接种（品牌和接种日期）、SARS-CoV-2 感染史（是/否以及阳性检测日期）、潜在混杂因素（人口、生殖和生活方式特征）以及怀孕状况的数据。疫苗接种状态分为从未（受孕前0剂）、曾经（受孕前≥1剂）、受孕前具有完整初级序列以及受孕前≤3个月完成完整初级序列。这些类别并不相互排斥。从第一次妊娠试验呈阳性开始对参与者进行随访，直至流产或审查事件（人工流产、宫外孕、失访、妊娠 20 周），以先发生者为准。我们使用以 GW 为时间尺度的 Cox 比例风险模型估计了流产的发生率比 (IRR) 和相应的 95% CI。我们使用倾向评分精细分层权重来调整混杂因素。 主要结果和机会的作用在 1815 名符合条件的女性参与者中，75% 的人在受孕时至少接种了一剂 COVID-19 疫苗。几乎四分之一的妊娠导致流产，75% 的流产发生在妊娠 8 周以内。将受孕前任何时间至少接种一剂的女性参与者与未接种疫苗的女性参与者进行比较，倾向得分加权 IRR 为 0.85（95% CI：0.63，1.14）。 COVID-19 疫苗接种与早期流产（GW：<8）或晚期流产（GW：8-19）的风险增加无关。没有迹象表明男性伴侣接种疫苗会增加流产风险（IRR = 0.90；95% CI：0.56，1.44）。 局限性和注意事项本研究依赖于自我报告的疫苗接种状况和感染史。因此，可能存在一些暴露状态的非差异性错误分类。虽然流产也有可能被错误分类，但该队列中的孕前队列设计和家庭妊娠测试的高流行率降低了...
STUDY QUESTIONTo what extent is preconception maternal or paternal coronavirus disease 2019 (COVID-19) vaccination associated with miscarriage incidence?SUMMARY ANSWERCOVID-19 vaccination in either partner at any time before conception is not associated with an increased rate of miscarriage.WHAT IS KNOWN ALREADYSeveral observational studies have evaluated the safety of COVID-19 vaccination during pregnancy and found no association with miscarriage, though no study prospectively evaluated the risk of early miscarriage (gestational weeks [GW] <8) in relation to COVID-19 vaccination. Moreover, no study has evaluated the role of preconception vaccination in both male and female partners.STUDY DESIGN, SIZE, DURATIONAn Internet-based, prospective preconception cohort study of couples residing in the USA and Canada. We analyzed data from 1815 female participants who conceived during December 2020–November 2022, including 1570 couples with data on male partner vaccination.PARTICIPANTS/MATERIALS, SETTING, METHODSEligible female participants were aged 21–45 years and were trying to conceive without use of fertility treatment at enrollment. Female participants completed questionnaires at baseline, every 8 weeks until pregnancy, and during early and late pregnancy; they could also invite their male partners to complete a baseline questionnaire. We collected data on COVID-19 vaccination (brand and date of doses), history of SARS-CoV-2 infection (yes/no and date of positive test), potential confounders (demographic, reproductive, and lifestyle characteristics), and pregnancy status on all questionnaires. Vaccination status was categorized as never (0 doses before conception), ever (≥1 dose before conception), having a full primary sequence before conception, and completing the full primary sequence ≤3 months before conception. These categories were not mutually exclusive. Participants were followed up from their first positive pregnancy test until miscarriage or a censoring event (induced abortion, ectopic pregnancy, loss to follow-up, 20 weeks’ gestation), whichever occurred first. We estimated incidence rate ratios (IRRs) for miscarriage and corresponding 95% CIs using Cox proportional hazards models with GW as the time scale. We used propensity score fine stratification weights to adjust for confounding.MAIN RESULTS AND THE ROLE OF CHANCEAmong 1815 eligible female participants, 75% had received at least one dose of a COVID-19 vaccine by the time of conception. Almost one-quarter of pregnancies resulted in miscarriage, and 75% of miscarriages occurred <8 weeks’ gestation. The propensity score-weighted IRR comparing female participants who received at least one dose any time before conception versus those who had not been vaccinated was 0.85 (95% CI: 0.63, 1.14). COVID-19 vaccination was not associated with increased risk of either early miscarriage (GW: <8) or late miscarriage (GW: 8–19). There was no indication of an increased risk of miscarriage associated with male partner vaccination (IRR = 0.90; 95% CI: 0.56, 1.44).LIMITATIONS, REASONS FOR CAUTIONThe present study relied on self-reported vaccination status and infection history. Thus, there may be some non-differential misclassification of exposure status. While misclassification of miscarriage is also possible, the preconception cohort design and high prevalence of home pregnancy testing in this cohort reduced the potential for under …