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  1. Article ; Online: Confirmed SARS-CoV-2 infection in Scottish neonates 2020-2022: a national, population-based cohort study.

    Goulding, Anna / McQuaid, Fiona / Lindsay, Laura / Agrawal, Utkarsh / Auyeung, Bonnie / Calvert, Clara / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Hillman, Sam / Hopcroft, Lisa / Hopkins, Leanne / McCowan, Colin / McLaughlin, Terry / Moore, Emily / Ritchie, Lewis / Simpson, Colin R / Taylor, Bob / Fenton, Lynda /
    Pollock, Louisa / Gale, Chris / Kurinczuk, Jennifer J / Robertson, Chris / Sheikh, Aziz / Stock, Sarah / Wood, Rachael

    Archives of disease in childhood. Fetal and neonatal edition

    2023  Volume 108, Issue 4, Page(s) 367–372

    Abstract: Objectives: To examine neonates in Scotland aged 0-27 days with SARS-CoV-2 infection confirmed by viral testing; the risk of confirmed neonatal infection by maternal and infant characteristics; and hospital admissions associated with confirmed neonatal ... ...

    Abstract Objectives: To examine neonates in Scotland aged 0-27 days with SARS-CoV-2 infection confirmed by viral testing; the risk of confirmed neonatal infection by maternal and infant characteristics; and hospital admissions associated with confirmed neonatal infections.
    Design: Population-based cohort study.
    Setting and population: All live births in Scotland, 1 March 2020-31 January 2022.
    Results: There were 141 neonates with confirmed SARS-CoV-2 infection over the study period, giving an overall infection rate of 153 per 100 000 live births (141/92 009, 0.15%). Among infants born to women with confirmed infection around the time of birth, the confirmed neonatal infection rate was 1812 per 100 000 live births (15/828, 1.8%). Two-thirds (92/141, 65.2%) of neonates with confirmed infection had an associated admission to neonatal or (more commonly) paediatric care. Six of these babies (6/92, 6.5%) were admitted to neonatal and/or paediatric intensive care; however, none of these six had COVID-19 recorded as their main diagnosis. There were no neonatal deaths among babies with confirmed infection.
    Implications and relevance: Confirmed neonatal SARS-CoV-2 infection was uncommon over the first 23 months of the pandemic in Scotland. Secular trends in the neonatal confirmed infection rate broadly followed those seen in the general population, although at a lower level. Maternal confirmed infection at birth was associated with an increased risk of neonatal confirmed infection. Two-thirds of neonates with confirmed infection had an associated admission to hospital, with resulting implications for the baby, family and services, although their outcomes were generally good. Ascertainment of confirmed infection depends on the extent of testing, and this is likely to have varied over time and between groups: the extent of unconfirmed infection is inevitably unknown.
    MeSH term(s) Pregnancy ; Infant, Newborn ; Infant ; Child ; Humans ; Female ; COVID-19/diagnosis ; COVID-19/epidemiology ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/diagnosis ; SARS-CoV-2 ; Cohort Studies ; Scotland/epidemiology ; Pregnancy Outcome/epidemiology
    Language English
    Publishing date 2023-01-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 2007331-8
    ISSN 1468-2052 ; 1359-2998
    ISSN (online) 1468-2052
    ISSN 1359-2998
    DOI 10.1136/archdischild-2022-324713
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Neonatal and maternal outcomes following SARS-CoV-2 infection and COVID-19 vaccination: a population-based matched cohort study.

    Lindsay, Laura / Calvert, Clara / Shi, Ting / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Hopcroft, Lisa E M / Hopkins, Leanne / Goulding, Anna / McLaughlin, Terry / Moore, Emily / Taylor, Bob / Bhaskaran, Krishnan / Katikireddi, Srinivasa Vittal / McCabe, Ronan / McCowan, Colin / Simpson, Colin R / Robertson, Chris / Sheikh, Aziz /
    Wood, Rachael / Stock, Sarah J

    Nature communications

    2023  Volume 14, Issue 1, Page(s) 5275

    Abstract: Understanding the impact of SARS-CoV-2 infection and COVID-19 vaccination in pregnancy on neonatal and maternal outcomes informs clinical decision-making. Here we report a national, population-based, matched cohort study to investigate associations ... ...

    Abstract Understanding the impact of SARS-CoV-2 infection and COVID-19 vaccination in pregnancy on neonatal and maternal outcomes informs clinical decision-making. Here we report 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 neonatal and maternal outcomes among women in Scotland with a singleton pregnancy ending at ≥20 weeks gestation. Neonatal outcomes are stillbirth, neonatal death, extended perinatal mortality, preterm birth (overall, spontaneous, and provider-initiated), small-for-gestational age, and low Apgar score. Maternal outcomes are admission to critical care or death, venous thromboembolism, hypertensive disorders of pregnancy, and pregnancy-related bleeding. We use conditional logistic regression to derive odds ratios adjusted for socio-demographic and clinical characteristics (aORs). We find that infection is associated with an increased risk of preterm (aOR=1.36, 95% Confidence Interval [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). We find no evidence of increased risk for any of our outcomes following vaccination. These data suggest SARS-CoV-2 infection during pregnancy is associated with adverse neonatal and maternal outcomes, and COVID-19 vaccination remains a safe way for pregnant women to protect themselves and their babies against infection.
    MeSH term(s) Adult ; Female ; Humans ; Infant, Newborn ; Pregnancy ; Cohort Studies ; COVID-19/pathology ; COVID-19 Vaccines/adverse effects ; Pregnancy Complications, Infectious/pathology ; Pregnancy Outcome
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2023-08-29
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-023-40965-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: COVID-19 in Pregnancy in Scotland (COPS): protocol for an observational study using linked Scottish national data.

    Stock, Sarah Jane / McAllister, David / Vasileiou, Eleftheria / Simpson, Colin R / Stagg, Helen R / Agrawal, Utkarsh / McCowan, Colin / Hopkins, Leanne / Donaghy, Jack / Ritchie, Lewis / Robertson, Chris / Sheikh, Aziz / Wood, Rachael

    BMJ open

    2020  Volume 10, Issue 11, Page(s) e042813

    Abstract: Introduction: The effects of SARS-CoV-2 in pregnancy are not fully delineated. We will describe the incidence of COVID-19 in pregnancy at population level in Scotland, in a prospective cohort study using linked data. We will determine associations ... ...

    Abstract Introduction: The effects of SARS-CoV-2 in pregnancy are not fully delineated. We will describe the incidence of COVID-19 in pregnancy at population level in Scotland, in a prospective cohort study using linked data. We will determine associations between COVID-19 and adverse pregnancy, neonatal and maternal outcomes and the proportion of confirmed cases of SARS-CoV-2 infection in neonates associated with maternal COVID-19.
    Methods and analysis: Prospective cohort study using national linked data sets. We will include all women in Scotland, UK, who were pregnant on or became pregnant after, 1 March 2020 (the date of the first confirmed case of SARS-CoV-2 infection in Scotland) and all births in Scotland from 1 March 2020 onwards. Individual-level data will be extracted from data sets containing details of all livebirths, stillbirth, terminations of pregnancy and miscarriages and ectopic pregnancies treated in hospital or attending general practice. Records will be linked within the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform, which includes primary care records, virology and serology results and details of COVID-19 Community Hubs and Assessment Centre contacts and deaths. We will perform analyses using definitions for confirmed, probable and possible COVID-19 and report serology results (where available). Outcomes will include congenital anomaly, miscarriage, stillbirth, termination of pregnancy, preterm birth, neonatal infection, severe maternal disease and maternal deaths. We will perform descriptive analyses and appropriate modelling, adjusting for demographic and pregnancy characteristics and the presence of comorbidities. The cohort will provide a platform for future studies of the effectiveness and safety of therapeutic interventions and immunisations for COVID-19 and their effects on childhood and developmental outcomes.
    Ethics and dissemination: COVID-19 in Pregnancy in Scotland is a substudy of EAVE II(, which has approval from the National Research Ethics Service Committee. Findings will be reported to Scottish Government, Public Health Scotland and published in peer-reviewed journals.
    MeSH term(s) Adult ; COVID-19/epidemiology ; Female ; Humans ; Incidence ; Infant, Newborn ; Pandemics ; Population Surveillance ; Pregnancy ; Pregnancy Complications, Infectious/epidemiology ; Premature Birth/epidemiology ; Prospective Studies ; SARS-CoV-2 ; Scotland/epidemiology
    Language English
    Publishing date 2020-11-26
    Publishing country England
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2020-042813
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Cohort Profile: The COVID-19 in Pregnancy in Scotland (COPS) dynamic cohort of pregnant women to assess effects of viral and vaccine exposures on pregnancy.

    Stock, Sarah J / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Goulding, Anna / Hopcroft, Lisa E M / Hopkins, Leanne / Mulholland, Rachel / Agrawal, Utkarsh / Auyeung, Bonnie / Katikireddi, Srinivasa Vittal / McCowan, Colin / Murray, Josie / Robertson, Chris / Sheikh, Aziz / Shi, Ting / Simpson, Colin R / Vasileiou, Eleftheria / Wood, Rachael

    International journal of epidemiology

    2021  Volume 51, Issue 5, Page(s) e245–e255

    MeSH term(s) COVID-19/prevention & control ; Female ; Humans ; Pregnancy ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/prevention & control ; Pregnant Women ; SARS-CoV-2 ; Vaccination ; Vaccines
    Chemical Substances Vaccines
    Language English
    Publishing date 2021-12-22
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 187909-1
    ISSN 1464-3685 ; 0300-5771
    ISSN (online) 1464-3685
    ISSN 0300-5771
    DOI 10.1093/ije/dyab243
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland.

    Stock, Sarah J / Carruthers, Jade / Calvert, Clara / Denny, Cheryl / Donaghy, Jack / Goulding, Anna / Hopcroft, Lisa E M / Hopkins, Leanne / McLaughlin, Terry / Pan, Jiafeng / Shi, Ting / Taylor, Bob / Agrawal, Utkarsh / Auyeung, Bonnie / Katikireddi, Srinivasa Vittal / McCowan, Colin / Murray, Josie / Simpson, Colin R / Robertson, Chris /
    Vasileiou, Eleftheria / Sheikh, Aziz / Wood, Rachael

    Nature medicine

    2022  Volume 28, Issue 3, Page(s) 504–512

    Abstract: Population-level data on COVID-19 vaccine uptake in pregnancy and SARS-CoV-2 infection outcomes are lacking. We describe COVID-19 vaccine uptake and SARS-CoV-2 infection in pregnant women in Scotland, using whole-population data from a national, ... ...

    Abstract Population-level data on COVID-19 vaccine uptake in pregnancy and SARS-CoV-2 infection outcomes are lacking. We describe COVID-19 vaccine uptake and SARS-CoV-2 infection in pregnant women in Scotland, using whole-population data from a national, prospective cohort. Between the start of a COVID-19 vaccine program in Scotland, on 8 December 2020 and 31 October 2021, 25,917 COVID-19 vaccinations were given to 18,457 pregnant women. Vaccine coverage was substantially lower in pregnant women than in the general female population of 18-44 years; 32.3% of women giving birth in October 2021 had two doses of vaccine compared to 77.4% in all women. The extended perinatal mortality rate for women who gave birth within 28 d of a COVID-19 diagnosis was 22.6 per 1,000 births (95% CI 12.9-38.5; pandemic background rate 5.6 per 1,000 births; 452 out of 80,456; 95% CI 5.1-6.2). Overall, 77.4% (3,833 out of 4,950; 95% CI 76.2-78.6) of SARS-CoV-2 infections, 90.9% (748 out of 823; 95% CI 88.7-92.7) of SARS-CoV-2 associated with hospital admission and 98% (102 out of 104; 95% CI 92.5-99.7) of SARS-CoV-2 associated with critical care admission, as well as all baby deaths, occurred in pregnant women who were unvaccinated at the time of COVID-19 diagnosis. Addressing low vaccine uptake rates in pregnant women is imperative to protect the health of women and babies in the ongoing pandemic.
    MeSH term(s) COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Testing ; COVID-19 Vaccines/therapeutic use ; Female ; Humans ; Pregnancy ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/prevention & control ; Pregnant Women ; Prospective Studies ; SARS-CoV-2 ; Vaccination
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2022-01-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-021-01666-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Author Correction: SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland.

    Stock, Sarah J / Carruthers, Jade / Calvert, Clara / Denny, Cheryl / Donaghy, Jack / Goulding, Anna / Hopcroft, Lisa E M / Hopkins, Leanne / McLaughlin, Terry / Pan, Jiafeng / Shi, Ting / Taylor, Bob / Agrawal, Utkarsh / Auyeung, Bonnie / Katikireddi, Srinivasa Vittal / McCowan, Colin / Murray, Josie / Simpson, Colin R / Robertson, Chris /
    Vasileiou, Eleftheria / Sheikh, Aziz / Wood, Rachael

    Nature medicine

    2022  Volume 28, Issue 3, Page(s) 599

    Language English
    Publishing date 2022-02-04
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-022-01730-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Pregnancy outcomes after SARS-CoV-2 infection in periods dominated by delta and omicron variants in Scotland: a population-based cohort study.

    Stock, Sarah J / Moore, Emily / Calvert, Clara / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Hillman, Sam / Hopcroft, Lisa E M / Hopkins, Leanne / Goulding, Anna / Lindsay, Laura / McLaughlin, Terry / Taylor, Bob / Auyeung, Bonnie / Katikireddi, Srinivasa Vittal / McCowan, Colin / Ritchie, Lewis D / Rudan, Igor / Simpson, Colin R /
    Robertson, Chris / Sheikh, Aziz / Wood, Rachael

    The Lancet. Respiratory medicine

    2022  Volume 10, Issue 12, Page(s) 1129–1136

    Abstract: Background: Evidence suggests that the SARS-CoV-2 omicron (B.1·1.529) is associated with lower risks of adverse outcomes than the delta (B.1.617.2) variant among the general population. However, little is known about outcomes after omicron infection in ... ...

    Abstract Background: Evidence suggests that the SARS-CoV-2 omicron (B.1·1.529) is associated with lower risks of adverse outcomes than the delta (B.1.617.2) variant among the general population. However, little is known about outcomes after omicron infection in pregnancy. We aimed to assess and compare short-term pregnancy outcomes after SARS-CoV-2 delta and omicron infection in pregnancy.
    Methods: We did a national population-based cohort study of women who had SARS-CoV-2 infection in pregnancy between May 17, 2021, and Jan 31, 2022. The primary maternal outcome was admission to critical care within 21 days of infection or death within 28 days of date of infection. Pregnancy outcomes were preterm birth and stillbirth within 28 days of infection. Neonatal outcomes were death within 28 days of birth, and low Apgar score (<7 of 10, for babies born at term) or neonatal SARS-CoV-2 infection in births occurring within 28 days of maternal infection. We used periods when variants were dominant in the general Scottish population, based on 50% or more of cases being S-gene positive (delta variant, from May 17 to Dec 14, 2021) or S-gene negative (omicron variant, from Dec 15, 2021, to Jan 31, 2022) as surrogates for variant infections. Analyses used logistic regression, adjusting for maternal age, deprivation quintile, ethnicity, weeks of gestation, and vaccination status. Sensitivity analyses included restricting the analysis to those with first confirmed SARS-CoV-2 infection and using periods when delta or omicron had 90% or more predominance.
    Findings: Between May 17, 2021, and Jan 31, 2022, there were 9923 SARS-CoV-2 infections in 9823 pregnancies, in 9817 women in Scotland. Compared with infections in the delta-dominant period, SARS-CoV-2 infections in pregnancy in the omicron-dominant period were associated with lower maternal critical care admission risk (0·3% [13 of 4968] vs 1·8% [89 of 4955]; adjusted odds ratio 0·25, 95% CI 0·14-0·44) and lower preterm birth within 28 days of infection (1·8% [37 of 2048] vs 4·2% [98 of 2338]; 0·57, 95% CI 0·38-0·87). There were no maternal deaths within 28 days of infection. Estimates of low Apgar scores were imprecise due to low numbers (5 [1·2%] of 423 with omicron vs 11 [2·1%] of 528 with delta, adjusted odds ratio 0·72, 0·23-2·32). There were fewer stillbirths in the omicron-dominant period than in the delta-dominant period (4·3 [2 of 462] per 1000 births vs 20·3 [13 of 639] per 1000) and no neonatal deaths during the omicron-dominant period (0 [0 of 460] per 1000 births vs 6·3 [4 of 626] per 1000 births), thus numbers were too small to support adjusted analyses. Rates of neonatal infection were low in births within 28 days of maternal SARS-CoV-2 infection, with 11 cases of neonatal SARS-CoV-2 in the delta-dominant period, and 1 case in the omicron-dominant period. Of the 15 stillbirths, 12 occurred in women who had not received two or more doses of COVID-19 vaccination at the time of SARS-CoV-2 infection in pregnancy. All 12 cases of neonatal SARS-CoV-2 infection occurred in women who had not received two or more doses of vaccine at the time of maternal infection. Findings in sensitivity analyses were similar to those in the main analyses.
    Interpretation: Pregnant women infected with SARS-CoV-2 were substantially less likely to have a preterm birth or maternal critical care admission during the omicron-dominant period than during the delta-dominant period.
    Funding: Wellcome Trust, Tommy's charity, Medical Research Council, UK Research and Innovation, Health Data Research UK, National Core Studies-Data and Connectivity, Public Health Scotland, Scottish Government Health and Social Care, Scottish Government Chief Scientist Office, National Research Scotland.
    MeSH term(s) Infant, Newborn ; Pregnancy ; Female ; Humans ; SARS-CoV-2 ; COVID-19 ; Pregnancy Outcome/epidemiology ; Cohort Studies ; Stillbirth/epidemiology ; Premature Birth/epidemiology ; COVID-19 Vaccines ; Pregnancy Complications, Infectious/epidemiology
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2022-10-07
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(22)00360-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection.

    Calvert, Clara / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Hopcroft, Lisa E M / Hopkins, Leanne / Goulding, Anna / Lindsay, Laura / McLaughlin, Terry / Moore, Emily / Taylor, Bob / Loane, Maria / Dolk, Helen / Morris, Joan / Auyeung, Bonnie / Bhaskaran, Krishnan / Gibbons, Cheryl L / Katikireddi, Srinivasa Vittal / O'Leary, Maureen /
    McAllister, David / Shi, Ting / Simpson, Colin R / Robertson, Chris / Sheikh, Aziz / Stock, Sarah J / Wood, Rachael

    Nature communications

    2023  Volume 14, Issue 1, Page(s) 107

    Abstract: Evidence on associations between COVID-19 vaccination or SARS-CoV-2 infection and the risk of congenital anomalies is limited. Here we report a national, population-based, matched cohort study using linked electronic health records from Scotland (May ... ...

    Abstract Evidence on associations between COVID-19 vaccination or SARS-CoV-2 infection and the risk of congenital anomalies is limited. Here we report a national, population-based, matched cohort study using linked electronic health records from Scotland (May 2020-April 2022) to estimate the association between COVID-19 vaccination and, separately, SARS-CoV-2 infection between six weeks pre-conception and 19 weeks and six days gestation and the risk of [1] any major congenital anomaly and [2] any non-genetic major congenital anomaly. Mothers vaccinated in this pregnancy exposure period mostly received an mRNA vaccine (73.7% Pfizer-BioNTech BNT162b2 and 7.9% Moderna mRNA-1273). Of the 6731 babies whose mothers were vaccinated in the pregnancy exposure period, 153 had any anomaly and 120 had a non-genetic anomaly. Primary analyses find no association between any vaccination and any anomaly (adjusted Odds Ratio [aOR] = 1.01, 95% Confidence Interval [CI] = 0.83-1.24) or non-genetic anomalies (aOR = 1.00, 95% CI = 0.81-1.22). Primary analyses also find no association between SARS-CoV-2 infection and any anomaly (aOR = 1.02, 95% CI = 0.66-1.60) or non-genetic anomalies (aOR = 0.94, 95% CI = 0.57-1.54). Findings are robust to sensitivity analyses. These data provide reassurance on the safety of vaccination, in particular mRNA vaccines, just before or in early pregnancy.
    MeSH term(s) Female ; Humans ; Pregnancy ; BNT162 Vaccine ; Cohort Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; SARS-CoV-2/genetics ; Vaccination/adverse effects
    Chemical Substances BNT162 Vaccine ; COVID-19 Vaccines
    Language English
    Publishing date 2023-01-06
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-022-35771-8
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  9. Article ; Online: Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study.

    Morling, Joanne R / McAllister, David A / Agur, Wael / Fischbacher, Colin M / Glazener, Cathryn M A / Guerrero, Karen / Hopkins, Leanne / Wood, Rachael

    Lancet (London, England)

    2016  Volume 389, Issue 10069, Page(s) 629–640

    Abstract: Background: Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.: ... ...

    Abstract Background: Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.
    Methods: We did a cohort study of women in Scotland aged 20 years or older undergoing a first, single incontinence procedure or prolapse procedure during 1997-98 to 2015-16 identified from a national hospital admission database. Primary outcomes were immediate postoperative complications and subsequent (within 5 years) readmissions for later postoperative complications, further incontinence surgery, or further prolapse surgery. Poisson regression models were used to compare outcomes after procedures carried out with and without mesh.
    Findings: Between April 1, 1997, and March 31, 2016, 16 660 women underwent a first, single incontinence procedure, 13 133 (79%) of which used mesh. Compared with non-mesh open surgery (colposuspension), mesh procedures had a lower risk of immediate complications (adjusted relative risk [aRR] 0·44 [95% CI 0·36-0·55]) and subsequent prolapse surgery (adjusted incidence rate ratio [aIRR] 0·30 [0·24-0·39]), and a similar risk of further incontinence surgery (0·90 [0·73-1·11]) and later complications (1·12 [0·98-1·27]); all ratios are for retropubic mesh. During the same time period, 18 986 women underwent a first, single prolapse procedure, 1279 (7%) of which used mesh. Compared with non-mesh repair, mesh repair of anterior compartment prolapse was associated with a similar risk of immediate complications (aRR 0·93 [95% CI 0·49-1·79]); an increased risk of further incontinence (aIRR 3·20 [2·06-4·96]) and prolapse surgery (1·69 [1·29-2·20]); and a substantially increased risk of later complications (3·15 [2·46-4·04]). Compared with non-mesh repair, mesh repair of posterior compartment prolapse was associated with a similarly increased risk of repeat prolapse surgery and later complications. No difference in any outcome was observed between vaginal and, separately, abdominal mesh repair of vaginal vault prolapse compared with vaginal non-mesh repair.
    Interpretation: Our results support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse cannot be recommended for primary prolapse repair. Both vaginal and abdominal mesh procedures for vaginal vault prolapse repair are associated with similar effectiveness and complication rates to non-mesh vaginal repair. These results therefore do not clearly favour any particular vault repair procedure.
    Funding: None.
    MeSH term(s) Adult ; Aged ; Cohort Studies ; Female ; Gynecologic Surgical Procedures/adverse effects ; Gynecologic Surgical Procedures/methods ; Humans ; Middle Aged ; Odds Ratio ; Pelvic Organ Prolapse/surgery ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Postoperative Complications/surgery ; Reconstructive Surgical Procedures/adverse effects ; Reconstructive Surgical Procedures/methods ; Regression Analysis ; Reoperation ; Scotland/epidemiology ; Suburethral Slings ; Surgical Mesh ; Urinary Incontinence, Stress/surgery ; Urologic Surgical Procedures/adverse effects ; Urologic Surgical Procedures/methods ; Vagina/surgery
    Language English
    Publishing date 2016-12-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(16)32572-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: A population-based matched cohort study of early pregnancy outcomes following COVID-19 vaccination and SARS-CoV-2 infection.

    Calvert, Clara / Carruthers, Jade / Denny, Cheryl / Donaghy, Jack / Hillman, Sam / Hopcroft, Lisa E M / Hopkins, Leanne / Goulding, Anna / Lindsay, Laura / McLaughlin, Terry / Moore, Emily / Pan, Jiafeng / Taylor, Bob / Almaghrabi, Fatima / Auyeung, Bonnie / Bhaskaran, Krishnan / Gibbons, Cheryl L / Katikireddi, Srinivasa Vittal / McCowan, Colin /
    Murray, Josie / O'Leary, Maureen / Ritchie, Lewis D / Shah, Syed Ahmar / Simpson, Colin R / Robertson, Chris / Sheikh, Aziz / Stock, Sarah J / Wood, Rachael

    Nature communications

    2022  Volume 13, Issue 1, Page(s) 6124

    Abstract: Data on the safety of COVID-19 vaccines in early pregnancy are limited. We conducted a national, population-based, matched cohort study assessing associations between COVID-19 vaccination and miscarriage prior to 20 weeks gestation and, separately, ... ...

    Abstract Data on the safety of COVID-19 vaccines in early pregnancy are limited. We conducted a national, population-based, matched cohort study assessing associations between COVID-19 vaccination and miscarriage prior to 20 weeks gestation and, separately, ectopic pregnancy. We identified women in Scotland vaccinated between 6 weeks preconception and 19 weeks 6 days gestation (for miscarriage; n = 18,780) or 2 weeks 6 days gestation (for ectopic; n = 10,570). Matched, unvaccinated women from the pre-pandemic and, separately, pandemic periods were used as controls. Here we show no association between vaccination and miscarriage (adjusted Odds Ratio [aOR], pre-pandemic controls = 1.02, 95% Confidence Interval [CI] = 0.96-1.09) or ectopic pregnancy (aOR = 1.13, 95% CI = 0.92-1.38). We undertook additional analyses examining confirmed SARS-CoV-2 infection as the exposure and similarly found no association with miscarriage or ectopic pregnancy. Our findings support current recommendations that vaccination remains the safest way for pregnant women to protect themselves and their babies from COVID-19.
    MeSH term(s) Female ; Humans ; Pregnancy ; Abortion, Spontaneous/epidemiology ; Cohort Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Influenza, Human/prevention & control ; Pregnancy Outcome ; Pregnancy, Ectopic ; SARS-CoV-2 ; Vaccination
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2022-10-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-022-33937-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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