Article Text

Protocol
Clinical manifestations, prevalence, risk factors, outcomes, transmission, diagnosis and treatment of COVID-19 in pregnancy and postpartum: a living systematic review protocol
  1. Magnus Yap1,
  2. Luke Debenham1,
  3. Tania Kew1,
  4. Shaunak Rhiju Chatterjee1,
  5. John Allotey2,3,
  6. Elena Stallings4,5,
  7. Dyuti Coomar3,
  8. Siang Ing Lee3,
  9. Xiu Qiu6,7,8,
  10. Mingyang Yuan3,7,
  11. Anna Clavé Llavall1,
  12. Anushka Dixit1,
  13. Dengyi Zhou1,
  14. Rishab Balaji1,
  15. Madelon van Wely9,
  16. Elena Kostova9,
  17. Elisabeth van Leeuwen10,
  18. Lynne Mofenson11,
  19. Heinke Kunst12,
  20. Asma Khalil13,
  21. Simon Tiberi12,14,
  22. James Thomas15,
  23. Vanessa Brizuela16,
  24. Nathalie Broutet16,
  25. Edna Kara16,
  26. Caron Kim16,
  27. Anna Thorson16,
  28. Pura Rayco-Solon16,
  29. Hector Pardo-Hernandez16,
  30. Olufemi Taiwo Oladapo16,
  31. Javier Zamora17,
  32. Mercedes Bonet16,
  33. Shakila Thangaratinam2,18
  34. On behalf of PregCOV-19 Consortium
  1. 1Birmingham Medical School, College Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  2. 2WHO Collaborating Centre for Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
  3. 3Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  4. 4Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain
  5. 5CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain
  6. 6Department of Woman and Child Health Care, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, China
  7. 7Division of Birth Cohort Study, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, China
  8. 8Department of Obstetrics and Gynecology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, China
  9. 9Netherlands Satellite of the Cochrane Gynaecology and Fertility Group, Amsterdam University Medical Center, Amsterdam, The Netherlands
  10. 10Department of Obstetrics and Gynaecology, Amsterdam University Medical Center, Amsterdam, The Netherlands
  11. 11Elizabeth Glaser Pediatric AIDS Foundation, Washington DC, Maryland, USA
  12. 12Blizard Institute, Queen Mary University of London, London, UK
  13. 13Department of Obstetrics and Gynaecology, St George’s University London, London, UK
  14. 14Department of Infectious Diseases, Barts Health NHS Trust, London, UK
  15. 15UCL Institute of Education, University College London, London, UK
  16. 16Department of Sexual and Reproductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland
  17. 17Women’s Health Research Unit, Queen Mary University of London, London, UK
  18. 18Department of Obstetrics and Gynaecology, Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, UK
  1. Correspondence to Dr John Allotey; j.allotey.1{at}bham.ac.uk

Abstract

Introduction Rapid, robust and continually updated evidence synthesis is required to inform management of COVID-19 in pregnant and postpartum women and to 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. Regular updates of the results will be published on a dedicated website (https://www.birmingham.ac.uk/research/who-collaborating-centre/pregcov/index.aspx) and disseminated through publications, social media and webinars.

PROSPERO registration number CRD42020178076.

  • maternal medicine
  • virology
  • neonatology
  • protocols & guidelines
  • perinatology
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Statistics from Altmetric.com

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • MY, LD, TK and SRC are joint first authors.

  • Twitter @balaji_rishab

  • Contributors All authors contributed to the development of the protocol and writing of the manuscript. MY, LD, TK, SRC—wrote the first draft of the manuscript. JA, ES—designed the study. DC, SIL—reviewed the manuscript and were involved in quality assessment and data extraction. They have approved the final version of the manuscript. ACL, AD, DZ, RB—reviewed the manuscript and are involved in study selection, and they have approved the final version of the manuscript. XQ, MY, MvW, EK, EvL, LM, HK, AK, ST, JT, VB, NB, EK, CK, AT, PR-S, HP-H, OTO—reviewed the manuscript, contributing critical changes, and they have approved the final version of the manuscript. JZ reviewed the manuscript and will conduct the statistical analysis. He approved the final version of the manuscript. MB designed the study, and reviewed the manuscript and has approved the final version of the manuscript. ST conceived and designed the study and reviewed the manuscript and approved the final version of the manuscript. ST is the guarantor. All authors reviewed the manuscript, contributing critical changes and approved the final version of the manuscript.

  • Funding The work is partially funded by the WHO. The authors alone are responsible for the views expressed in this manuscript and they do not necessarily represent the decisions, policy or views of the funding bodies. The views of the funding bodies have not influenced the content of this manuscript.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.