Coronavirus Disease 2019 (COVID-19) Vaccination and Stillbirth in the Vaccine Safety Datalink.

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrics and gynecology Pub Date : 2024-08-01 Epub Date: 2024-06-06 DOI:10.1097/AOG.0000000000005632

Anna E Denoble, Gabriela Vazquez-Benitez, Sangini S Sheth, Christina M Ackerman-Banks, Malini B DeSilva, Jingyi Zhu, Matthew F Daley, Darios Getahun, Nicola P Klein, Kimberly K Vesco, Stephanie A Irving, Jennifer Nelson, Joshua T B Williams, Simon J Hambidge, James G Donahue, Eric S Weintraub, Elyse O Kharbanda, Heather S Lipkind

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引用次数: 0

Abstract

Objective: Coronavirus disease 2019 (COVID-19) vaccination is recommended in pregnancy to reduce the risk of severe morbidity from COVID-19. However, vaccine hesitancy persists among pregnant people, with risk of stillbirth being a primary concern. Our objective was to examine the association between COVID-19 vaccination and stillbirth.

Methods: We performed a matched case-control study in the Vaccine Safety Datalink (VSD). Stillbirths and live births were selected from singleton pregnancies among persons aged 16-49 years with at least one prenatal, delivery, or postpartum visit at eight participating VSD sites. Stillbirths identified through diagnostic codes were adjudicated to confirm the outcome, date, and gestational age at fetal death. Confirmed antepartum stillbirths that occurred between February 14, 2021, and February 27, 2022, then were matched 1:3 to live births by pregnancy start date, VSD site, and maternal age at delivery. Associations among antepartum stillbirth and COVID-19 vaccination in pregnancy, vaccine manufacturer, number of vaccine doses received, and vaccination within 6 weeks before stillbirth (or index date in live births) were evaluated using conditional logistic regression.

Results: In the matched analysis of 276 confirmed antepartum stillbirths and 822 live births, we found no association between COVID-19 vaccination during pregnancy and stillbirth (38.4% stillbirths vs 39.3% live births in vaccinated individuals, adjusted odds ratio [aOR] 1.02, 95% CI, 0.76-1.37). Furthermore, no association between COVID-19 vaccination and stillbirth was detected by vaccine manufacturer (Moderna: aOR 1.00, 95% CI, 0.62-1.62; Pfizer-BioNTech: aOR 1.00, 95% CI, 0.69-1.43), number of vaccine doses received during pregnancy (1 vs 0: aOR 1.17, 95% CI, 0.75-1.83; 2 vs 0: aOR 0.98, 95% CI, 0.81-1.17), or COVID-19 vaccination within the 6 weeks before stillbirth or index date compared with no vaccination (aOR 1.16, 95% CI, 0.74-1.83).

Conclusion: No association was found between COVID-19 vaccination and stillbirth. These findings further support recommendations for COVID-19 vaccination in pregnancy.

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疫苗安全数据链中的 2019 年冠状病毒病（COVID-19）疫苗接种与死胎。

目的：建议孕妇接种 2019 年冠状病毒病（COVID-19）疫苗，以降低 COVID-19 严重发病的风险。然而，孕妇仍对接种疫苗犹豫不决，死产的风险是她们最担心的问题。我们的目的是研究 COVID-19 疫苗接种与死胎之间的关系：我们在疫苗安全数据链 (VSD) 中进行了一项匹配病例对照研究。死胎和活产都是从 16-49 岁的单胎孕妇中挑选出来的，这些孕妇至少在 VSD 的 8 个参与地点进行过一次产前、分娩或产后检查。通过诊断代码确定的死胎将被裁定，以确认胎儿死亡的结果、日期和胎龄。经确认的产前死胎发生在 2021 年 2 月 14 日至 2022 年 2 月 27 日之间，然后按照怀孕开始日期、VSD 地点和产妇分娩年龄与活产婴儿进行 1:3 配对。使用条件逻辑回归评估了产前死胎与孕期接种 COVID-19 疫苗、疫苗生产商、接种疫苗剂量以及死胎前 6 周内接种疫苗（或活产中的指数日期）之间的关系：在对 276 例确诊的产前死胎和 822 例活产进行的匹配分析中，我们发现孕期接种 COVID-19 疫苗与死胎之间没有关联（接种疫苗者的死胎率为 38.4%，活产率为 39.3%，调整后的几率比 [aOR] 为 1.02，95% CI 为 0.76-1.37）。此外，从疫苗生产商（Moderna：aOR 1.00，95% CI，0.62-1.62；辉瑞生物技术公司：aOR 1.00，95% CI，0.69-1.43）、孕期接种疫苗剂量（1 vs 0：aOR 1.17，95% CI，0.75-1.83；2 vs 0：aOR 0.98，95% CI，0.81-1.17），或死产前或指数日期前 6 周内接种 COVID-19 疫苗与未接种相比（aOR 1.16，95% CI，0.74-1.83）：结论：COVID-19疫苗接种与死产之间没有关联。这些结果进一步支持了在孕期接种 COVID-19 疫苗的建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Obstetrics and gynecology 医学-妇产科学

CiteScore

11.10

自引率

4.20%

发文量

867

审稿时长

1 months

期刊介绍： "Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics. "Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.