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. 2021 Jan 29;11(1):e041247.
doi: 10.1136/bmjopen-2020-041247.

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

Jayanta Banerjee  1   2 , Edward Mullins  2   3 , Julia Townson  4 , Rebecca Playle  4 , Caroline Shaw  2   3 , Nigel Kirby  4 , Kim Munnery  4 , Tom Bourne  2 , T G Teoh  2   5 , Mandish Dhanjal  5 , Liona Poon  6 , Alison Wright  7 , Christoph Lees  8   3   5
Affiliations

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

Jayanta Banerjee et al. BMJ Open. .

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Study registration number: ISRCTN68026880.

Keywords: infectious diseases; neonatology; obstetrics; public health.

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Conflict of interest statement

Competing interests: None declared.

References

    1. Di Mascio D Outcome of coronavirus spectrum infections (SARS, MERS, COVID 1 -19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM 2020. - PMC - PubMed
    1. Lopes Moreira ME, Nielsen-Saines K, Brasil P, et al. . Neurodevelopment in infants exposed to Zika virus in utero. N Engl J Med 2018;379:2377–9. 10.1056/NEJMc1800098 - DOI - PMC - PubMed
    1. Olival KJ, Hosseini PR, Zambrana-Torrelio C. Host and viral traits predict zoonotic spillover from mammals. Nature 2017. 10.1038/nature22975 - DOI - PMC - PubMed
    1. Joly D, Johnson CK, Goldstein T. The first phase of predict: surveillance for emerging infectious zoonotic diseases of wildlife origin (2009-2014). Int J Infect Dis 2016. 10.1016/j.ijid.2016.11.086 - DOI
    1. Li AM, Ng PC. Severe acute respiratory syndrome (SARS) in neonates and children. Arch Dis Child Fetal Neonatal Ed 2005;90:F461–5. 10.1136/adc.2005.075309 - DOI - PMC - PubMed

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