Download This Paper
Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.
Baby and Maternal Outcomes Following SARS-CoV-2 Infection and COVID-19 Vaccination During Pregnancy: A National Population-Based Matched Cohort Study
22 Pages Posted: 20 Jan 2023
More...Abstract
Background: Understanding the impact of SARS-CoV-2 infection and COVID-19 vaccination in pregnancy on maternal and perinatal outcomes informs clinical decision-making.
Methods: We undertook a national, population-based, matched cohort study to investigate associations between SARS-CoV-2 infection and, separately, COVID-19 vaccination just before or during pregnancy and the risk of adverse baby and maternal outcomes among women in Scotland with a singleton pregnancy ending at ≥20 weeks gestation. Baby outcomes examined were stillbirth, neonatal death, extended perinatal mortality, preterm birth (overall, spontaneous, and provider-initiated), small-for-gestational age, and low Apgar score. Maternal outcomes were admission to critical care or death, venous thromboembolism, hypertensive disorders of pregnancy, and pregnancy-related bleeding. Conditional logistic regression models were used to derive odds ratios adjusted for socio-demographic and clinical characteristics (aORs) and 95% confidence intervals (CIs).
Findings: Our infection analyses of 4,074 women with confirmed SARS-CoV-2 infection matched on maternal age, season of conception, and gestational age at infection/matching to 12,222 uninfected controls, found that infection was associated with an increased risk of preterm (aOR=1·36, 95% CI 1·16-1·59) and very preterm birth (aOR=1·90, 95% CI 1·20-3·02), maternal admission to critical care or death (aOR=1·72, 95% CI 1·39-2·12), and venous thromboembolism (aOR=2·53, 95% CI 1·47-4·35). Our vaccination analyses found no evidence of increased risk for any baby or maternal outcomes following vaccination.InterpretationSARS-CoV-2 infection during pregnancy is associated with adverse baby and maternal outcomes, but COVID-19 vaccination is not. COVID-19 vaccination remains the safest way for pregnant women to protect themselves and their babies against SARS-CoV-2 infection.
Funding: Our thanks to the EAVE II Patient Advisory Group and Sands charity for their support. COPS is a sub-study of EAVE II, which is funded by the Medical Research Council (MC_PC_19075) with the support of BREATHE – The Health Data Research Hub for Respiratory Health [MC_PC_19004], which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. Additional support has been provided through Public Health Scotland and Scottish Government DG Health and Social Care and the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation. COPS has received additional funding from Tommy’s charity. SJS is funded by a Wellcome Trust Clinical Career Development Fellowship (209560/Z/17/Z). SVK acknowledges funding from a NRS Senior Clinical Fellowship (SCAF/15/02), the Medical Research Council (MC_UU_00022/2) and the Scottish Government Chief Scientist Office (SPHSU17).
Declaration of Interests: AS and CR were members of the Scottish Government’s COVID-19 Advisory Group. AS is a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) risk stratification subgroup and the Scottish Government’s Committee on Pandemic Preparedness. CR is a member of the Scientific Pandemic Influenza Group on Modelling and the MHRA Covid 19 Vaccine Benefit and Risk Working Group. AS is a member of AstraZeneca’s Thrombotic Thrombocytopenic Advisory Group. All roles are unremunerated. SVK was co-chair of Scottish Government’s Expert Reference Group on Ethnicity and COVID-19. All others have nothing to declare.
Ethics Approval: COPS has ethical approval from the National Research Ethics Service Committee, South East Scotland 02 (REC 12/SS/0201: SA 2) and information governance approval from the Public Benefit and Privacy Panel for Health and Social Care (2021-0116).
Keywords: SARS-CoV-2, COVID-19, vaccination, pregnant women, pregnancy, baby, preterm birth
Suggested Citation: Suggested Citation