COVID-19 in Pregnancy in Scotland (COPS): protocol for an observational study using linked Scottish national data.
COVID-19 in Pregnancy in Scotland (COPS): protocol for an observational study using linked Scottish national data.
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DOI：
10.1136/bmjopen-2020-042813
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发表时间：
2020-11-26
期刊：
影响因子：
2.9
通讯作者：
Wood R
中科院分区：
文献类型：
--
作者：
Stock SJ;McAllister D;Vasileiou E;Simpson CR;Stagg HR;Agrawal U;McCowan C;Hopkins L;Donaghy J;Ritchie L;Robertson C;Sheikh A;Wood R
SARS-CoV-2对妊娠的影响还没有完全描述出来。在一项使用关联数据的前瞻性队列研究中，我们将描述苏格兰人群水平上新冠肺炎的怀孕发生率。我们将确定新冠肺炎与不良妊娠、新生儿和孕产妇结局的关系，以及与母亲新冠肺炎相关的新生儿中确诊SARS-CoV-2感染的比例。使用国家关联数据集的前瞻性队列研究。我们将包括所有在2020年3月1日(苏格兰首例确诊SARS-CoV-2感染病例的日期)怀孕或在此之后怀孕的英国苏格兰妇女，以及从2020年3月1日起在苏格兰出生的所有婴儿。个人一级的数据将从数据集中提取，其中包含在医院或全科医生接受治疗的所有活产、死产、终止妊娠和流产以及宫外孕的细节。记录将与新冠肺炎大流行早期评估和加强监测(Eave II)平台链接，该平台包括初级保健记录、病毒学和血清学结果以及新冠肺炎社区中心和评估中心接触者和死亡人数的详细信息。我们将使用确认的、可能的和可能的新冠肺炎的定义进行分析，并报告血清学结果(如果有)。结果将包括先天性异常、流产、死产、终止妊娠、早产、新生儿感染、严重孕产妇疾病和孕产妇死亡。我们将进行描述性分析和适当的建模，根据人口统计和怀孕特征以及合并疾病的存在进行调整。该队列将为未来研究新冠肺炎治疗干预和免疫的有效性和安全性及其对儿童和发育结果的影响提供一个平台。苏格兰怀孕期间的新冠肺炎是Eave II(已获得国家研究伦理服务委员会批准)的子研究。调查结果将报告给苏格兰政府，苏格兰公共卫生部门，并在同行评议的期刊上发表。
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. 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. 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.
影响因子：
7.7
作者：
Pique-Regi, Roger;Romero, Roberto;Gomez-Lopez, Nardhy
通讯作者：
Gomez-Lopez, Nardhy
影响因子：
15.8
作者：
Benchimol EI;Smeeth L;Guttmann A;Harron K;Moher D;Petersen I;Sørensen HT;von Elm E;Langan SM;RECORD Working Committee
通讯作者：
RECORD Working Committee