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Multicountry study protocol of COCOON: COntinuing Care in COVID-19 Outbreak global survey of New, expectant, and bereaved parent experiences
  1. Siobhan A Loughnan1,
  2. Rupesh Gautam1,
  3. Sergio A Silverio2,
  4. Frances M Boyle1,3,
  5. Jillian Cassidy4,
  6. David Ellwood1,5,
  7. Caroline Homer6,
  8. Dell Horey1,7,
  9. Susannah H Leisher8,
  10. Francine de Montigny9,
  11. Margaret Murphy10,
  12. Keelin O'Donoghue11,
  13. Paula Quigley8,12,
  14. Claudia Ravaldi13,14,
  15. Jane Sandall2,
  16. Claire Storey8,
  17. Alfredo Vannacci13,14,
  18. Alyce N Wilson6,
  19. Vicki Flenady1
  20. COCOON Global Collaboration
    1. 1NHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-The University of Queensland, Brisbane, QLD, Australia
    2. 2Department of Women & Children's Health, School of Life Course Sciences, King's College London, London, UK
    3. 3Institute for Social Science Research, The University of Queensland, Brisbane, Queensland, Australia
    4. 4Asociación Umamanita, Girona, Spain
    5. 5School of Medicine and Dentistry, Griffith University, Gold Coast, Queensland, Australia
    6. 6Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia
    7. 7Department of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia
    8. 8International Stillbirth Alliance, Millburn, New Jersey, USA
    9. 9Département des Sciences Infirmières, Université du Québec en Outaouais, Gatineau, Quebec, Canada
    10. 10Nursing and Midwifery, University College Cork–National University of Ireland, Cork, Ireland
    11. 11Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, University College Cork, Cork, Ireland
    12. 12DAI Global Health, London, UK
    13. 13CiaoLapo Foundation for Perinatal Health, Prato, Italy
    14. 14PeaRL - Perinatal Research Laboratory, Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Firenze, Italy
    1. Correspondence to Dr Siobhan A Loughnan; siobhan.loughnan{at}


    Introduction Globally, the COVID-19 pandemic has significantly disrupted the provision of healthcare and efficiency of healthcare systems and is likely to have profound implications for pregnant and postpartum women and their families including those who experience the tragedy of stillbirth or neonatal death. This study aims to understand the psychosocial impact of COVID-19 and the experiences of parents who have accessed maternity, neonatal and bereavement care services during this time.

    Methods and analysis An international, cross-sectional, online and/or telephone-based/face-to-face survey is being administered across 15 countries and available in 11 languages. New, expectant and bereaved parents during the COVID-19 pandemic will be recruited. Validated psychometric scales will be used to measure psychosocial well-being. Data will be analysed descriptively and by assessing multivariable associations of the outcomes with explanatory factors. In seven of these countries, bereaved parents will be recruited to a nested, qualitative interview study. The data will be analysed using a grounded theory analysis (for each country) and thematic framework analysis (for intercountry comparison) to gain further insights into their experiences.

    Ethics and dissemination Ethics approval for the multicountry online survey, COCOON, has been granted by the Mater Misericordiae Human Research Ethics Committee in Australia (reference number: AM/MML/63526). Ethics approval for the nested qualitative interview study, PUDDLES, has been granted by the King’s College London Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference number: HR-19/20-19455) in the UK. Local ethics committee approvals were granted in participating countries where required. Results of the study will be published in international peer-reviewed journals and through parent support organisations. Findings will contribute to our understanding of delivering maternity care services, particularly bereavement care, in high-income, lower middle-income and low-income countries during this or future health crises.

    • COVID-19

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    • Twitter @LoughnanSiobhan, @Silverio_SA_, @CarolineHomer, @dell_horey, @mgtmurphy123, @AlfVann

    • Collaborators COCOON Global Collaboration: Joycelyn Abiog-Filoteo, Neelam Aggarwal, Roberto Bonaiuti, Billie Bradford, Belinda Buenafe, Michelle Carty, Paul Cassidy, Sara Crocker, Robin Cronin, Rakhi Dandona, Joanne Durham, Abigail Easter, Madeline Forbes, Alison Griffin, Sanne Gordijn, Mechthild M Gross, Rebecca Guarino, Wendy Hall, Katharina Hartmann, Guilherme de Jesus, Inderjeet Kaur, Joemer Calderon Maravilla, Lesley McCowan, Lucila Castanheira Nascimento, Alonkone Phengsvanh, Wilfredo Quijencio Jr, Larissa Rossen, Jessica Ruidiaz, Vanphanom Sychareun, Alma Taragua, Sowmya Thota, Fatima Vera.

    • Contributors VF and CH conceived the study. SAL led the development of the study protocol with RG, SAS, FMB, JC, VF, CH, DH, SHL, FdM, MM, KO'D, PQ, CR, CS, JS, AV and ANW. All coauthors listed in the COCOON collaboration participated in the development and design of the COCOON study for their country coordinating centre. SAL and RG drafted the manuscript with SAS, FMB, DE and VF. All coauthors have contributed to the revision of the first draft and have approved the final manuscript.

    • Funding This study is funded by investigator VF and the Mater Research Institute, The University of Queensland, Brisbane, Australia. SAS and JS (King’s College London) are supported by the National Institute for Health Research Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. SAS is also in receipt of a Personal Doctoral Fellowship Award from the NIHR ARC South London Capacity Building Theme; and JS is also supported by the NIHR Senior Investigator Awards. The training and infrastructure of the PUDDLES Global Collaboration on Perinatal Bereavement is supported by the King’s College London Global Engagement Partnership Fund successfully awarded to JS (ref: PF2021_Mar_039).

    • Disclaimer The views expressed are those of the authors and not necessarily those of the funders.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • 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.