Pregnancy and neonatal outcomes in COVID-19: study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention.

Pregnancy and neonatal outcomes in COVID-19: study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention.
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DOI:
10.1136/bmjopen-2020-041247
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发表时间:
2021-01-29
期刊:
影响因子:
2.9
通讯作者:
Lees C
Lees C
中科院分区:
医学3区
文献类型:
--
作者:
Banerjee J;Mullins E;Townson J;Playle R;Shaw C;Kirby N;Munnery K;Bourne T;Teoh TG;Dhanjal M;Poon L;Wright A;Lees C

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此前的新型COVID-19大流行、SARS和中东呼吸综合征观察到妊娠感染与早产、死产和孕产妇死亡率增加有关。由SARS-CoV-2感染引起的COVID-19是人们记忆中最大的流行病。快速积累关于受疑似COVID-19或确诊SARS-CoV-2感染影响的怀孕妇女及其婴儿的可靠病例数据,将为当前大流行和未来爆发的临床管理和预防策略提供信息。COVID-19(PAN-COVID)登记研究中的妊娠和新生儿结局是一项观察性研究,通过门户网站收集关于妊娠期间疑似COVID-19或确诊SARS-CoV-2感染的孕妇及其新生儿结局的重点数据。在PAN-COVID登记处招募的女性中,该研究将评估以下事件的发生率:(1)流产和妊娠丢失,(2)胎儿生长受限和死产,(3)早产,(4)垂直传播(疑似或确诊)和早发性新生儿SARS-CoV-2感染。数据将以中心为基础,收集个别妇女及其婴儿的数据。将获得口头同意,以减少大流行期间的面对面接触,同时允许收集可识别的数据以进行联系。将由研究统计学家对简化的数据集进行数据统计分析。定期报告将分发给合作者的研究问题。该研究已在英国获得研究伦理批准。对于国际中心,在将数据输入数据库之前,需要提供适当的当地批准证据。这些报告将定期公布。研究成果将定期通过研究网站(https://www.example.com)和社交媒体渠道向参与者和合作者传播,并向科学会议和期刊传播。pan-covid.org ISRCTN68026880。
Previous novel COVID-19 pandemics, SARS and middle east respiratory syndrome observed an association of infection in pregnancy with preterm delivery, stillbirth and increased maternal mortality. COVID-19, caused by SARS-CoV-2 infection, is the largest pandemic in living memory. Rapid accrual of robust case data on women in pregnancy and their babies affected by suspected COVID-19 or confirmed SARS-CoV-2 infection will inform clinical management and preventative strategies in the current pandemic and future outbreaks. The pregnancy and neonatal outcomes in COVID-19 (PAN-COVID) registry are an observational study collecting focused data on outcomes of pregnant mothers who have had suspected COVID-19 in pregnancy or confirmed SARS-CoV-2 infection and their neonates via a web-portal. Among the women recruited to the PAN-COVID registry, the study will evaluate the incidence of: (1) miscarriage and pregnancy loss, (2) fetal growth restriction and stillbirth, (3) preterm delivery, (4) vertical transmission (suspected or confirmed) and early onset neonatal SARS-CoV-2 infection. Data will be centre based and collected on individual women and their babies. Verbal consent will be obtained, to reduce face-to-face contact in the pandemic while allowing identifiable data collection for linkage. Statistical analysis of the data will be carried out on a pseudonymised data set by the study statistician. Regular reports will be distributed to collaborators on the study research questions. This study has received research ethics approval in the UK. For international centres, evidence of appropriate local approval will be required to participate, prior to entry of data to the database. The reports will be published regularly. The outputs of the study will be regularly disseminated to participants and collaborators on the study website (https://pan-covid.org) and social media channels as well as dissemination to scientific meetings and journals. ISRCTN68026880.
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