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A core outcome set for stillbirth care: an international consensus study
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  • Danya Bakhbakhi,
  • Anna Davies,
  • Dimitrios Siassakos,
  • Lisa Hinton,
  • James Duffy,
  • Heatherjane Dangerfield,
  • Maggie Redshaw,
  • Abi Merriel,
  • Amy Howell,
  • Alexander Heazell,
  • Christy Burden,
  • Abigail Fraser
Danya Bakhbakhi
University of Bristol Translational Health Sciences

Corresponding Author:danya.bakhbakhi@bristol.ac.uk

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Anna Davies
University of Bristol Translational Health Sciences
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Dimitrios Siassakos
University College London
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Lisa Hinton
University of Oxford Nuffield Department of Primary Care Health Sciences
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James Duffy
St Bartholomew's Hospital
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Heatherjane Dangerfield
Sands and iCHOOSE parent and public representative
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Maggie Redshaw
Brazelton Centre
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Abi Merriel
University of Liverpool
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Amy Howell
University of Bristol Translational Health Sciences
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Alexander Heazell
The University of Manchester Maternal and Fetal Health Research Centre
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Christy Burden
University of Bristol Translational Health Sciences
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Abigail Fraser
University of Bristol Population Health Sciences
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Abstract

Objective To develop a core outcome set for stillbirth care. Design Consensus development study. Setting International. Population 542 participants from 29 countries, including 381 parents or family members who have experienced stillbirth, 192 care professionals and researchers (31 of which identified as both parent and professional). Methods Modified Delphi method and Modified Nominal Group Technique. Results A long list of 108 potential outcomes was developed by combining outcomes reported in 240 stillbirth care studies with those derived from interviews of 40 parents and family members with lived experience of stillbirth. Following a two-round Delphi process with consensus meetings, stakeholders agreed upon 8 core outcomes to measure in all stillbirth care studies; an additional 11 outcomes for specific interventions or care were also decided. Core outcomes for all stillbirth care studies were life-threatening complications and maternal death, parents’ experience of respectful and supportive care, grief, mental health and emotional wellbeing, isolation, stigma, impact on work, impact on relationship with immediate family. Outcomes for studies assessing interventions to understand the cause of stillbirth (investigations): cause of death identified and parents’ understanding of cause of death. Outcomes in studies assessing subsequent pregnancy after stillbirth: antenatal complications for mother, antenatal complications for baby, survival of baby, neonatal outcomes and attachment to baby. Outcomes for when a stillbirth occurs in a multiple pregnancy: Survival of other baby/ies, preterm birth, pregnancy complications for baby/ies and neonatal outcomes. Conclusion This core outcome set for stillbirth care should now be used in future trials and systematic reviews to ensure that outcomes considered important by a range of stakeholders are addressed, and to minimise outcome reporting bias.