Clinical manifestations, prevalence, risk factors, outcomes, transmission, diagnosis and treatment of COVID-19 in pregnancy and postpartum: a living systematic review protocol

PregCOV-19 Consortium

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Introduction: Rapid, robust and continually updated evidence synthesis is required to inform management of COVID-19 (coronavirus disease) in pregnant and postpartum women, and keep pace with the emerging evidence during the pandemic.

Methods and analysis: We plan to undertake a living systematic review to assess the prevalence, clinical manifestations, risk factors, rates of maternal and perinatal complications, potential for mother-to-child transmission, accuracy of diagnostic tests and effectiveness of treatment for COVID-19 in pregnant and postpartum women (including after miscarriage or abortion). We will search Medline, Embase, WHO COVID-19 database, preprint servers, the China National Knowledge Infrastructure system and Wanfang databases from 1 December 2019. We will supplement our search with studies mapped by Cochrane Fertility and Gynaecology group, Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), COVID-19 study repositories, reference lists and social media blogs. The search will be updated every week and not be restricted by language. We will include observational cohort (≥10 participants) and randomised studies reporting on prevalence of COVID-19 in pregnant and postpartum women, the rates of clinical manifestations and outcomes, risk factors in pregnant and postpartum women alone or in comparison with non-pregnant women with COVID-19 or pregnant women without COVID-19 and studies on tests and treatments for COVID-19. We will additionally include case reports and series with evidence on mother-to-child transmission of SARS-CoV-2 in utero, intrapartum or postpartum. We will appraise the quality of the included studies using appropriate tools to assess the risk of bias. At least two independent reviewers will undertake study selection, quality assessment and data extraction every 2 weeks. We will synthesise the findings using quantitative random effects meta-analysis and report OR or proportions with 95% CIs and prediction intervals. Case reports and series will be reported as qualitative narrative synthesis. Heterogeneity will be reported as I2 and τ2 statistics.

Ethics and dissemination: Ethical approval is not required as this is a synthesis of primary data. Updates every 6-8 weeks of the results will be published on a dedicated website and disseminated through publications, social media and webinars.

PROSPERO registration number: CRD42020178076

Strengths and limitations of this study:

●Our living systematic review will be underpinned by a comprehensive literature search, study quality assessment, and appropriate planned meta-analysis to efficiently collate the overall findings on COVID-19 in pregnant and postpartum women.
●We will continuously update our search, study selection, data extraction, analysis and reporting of the findings at pre-specified time intervals.
●Rapid publication of new studies with new outcomes of interest, screening and testing strategies and reporting of novel treatments may require changes in the review protocol, specifically regarding data extraction and search strategies for future updates.
●This review may be subject to publication bias, since studies with perceived positive results may be published faster than those with perceived negative results. We will continuously review registries of randomised controlled trials to detect trials that should have reported results but that have not done so and will contact corresponding authors to obtain results.
●The dynamic nature of the living systematic review requires dedicated team of committed researchers and resources, efficient peer review and support of the journal editors, to ensure that findings are rapidly published in the public domain with provision for continuous updates to inform living guidelines and policies.
Original languageEnglish
Article numbere041868
Number of pages7
JournalBMJ open
Issue number12
Publication statusPublished - 2 Dec 2020


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