A core outcome set for stillbirth care: an international consensus study

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). 95.6% of parents and 86.5% of professional stakeholders were from in high-income countries. Methods: Modified Delphi method and consensus meetings. Results: 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 the 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 can be used in future trials and systematic reviews to minimise outcome-reporting bias, allow comparability of interventions in meta-analyses and ultimately reduce research wastage.