New Core Outcomes May Transform Stillbirth Care

TOPLINE:

A new core outcome set for stillbirth care developed with the input from international stakeholders can be used in future trials and systematic reviews to reduce outcome-reporting bias, facilitate comparisons of interventions in meta-analyses, and ultimately reduce research wastage.

METHODOLOGY:

• Researchers conducted an international consensus study using data from the modified Delphi method and consensus meetings to develop a core outcome set to guide future stillbirth care research.
• The core outcome set was developed following the methodological consensus standards outlined by the Core Outcome Measures in Effectiveness Trials initiative standards and supported by the relevant published literature.
• Researchers invited 542 stakeholders, including 381 parents or family members who had experienced stillbirth and 192 healthcare professionals or researchers (31 of whom identified as both a parent and a professional), from 29 countries across Africa, Australia, Europe, North America, South America, and Asia.
• Participants completed two rounds of Delphi surveys using Research Electronic Data Capture, followed by four consensus meetings to determine the final core outcome set.

TAKEAWAY:

• Core outcomes for all stillbirth care studies were life-threatening complications, maternal death, parents’ experience of respectful and supportive care, grief, mental health and emotional well-being, isolation, stigma, impact on work, and impact on family relationships.
• For studies investigating the cause of stillbirth, researchers identified two additional core outcomes: identification of the cause of death and parents’ understanding of that cause.
• Studies assessing subsequent pregnancy care should measure outcomes such as antenatal complications for the mother and baby, baby survival, neonatal outcomes, and attachment to the baby.
• Studies focusing on stillbirth associated with a multiple pregnancy should consider outcomes such as survival of other babies, preterm birth, pregnancy complications for the baby, and neonatal outcomes.

IN PRACTICE:

“The development of a minimum agreed set of outcomes represents a significant milestone to address inconsistent outcome collection and reporting in studies of care after stillbirth,” the authors wrote.

SOURCE:

This study was led by Danya Bakhbakhi, Translational Health Sciences, University of Bristol, Bristol, England. It was published online on July 07, 2025, in BJOG: An International Journal of Obstetrics & Gynaecology.

LIMITATIONS:

Overall, 69.8% of participating parents had university or college education, which is higher than the population average, potentially affecting the generalisability of the core outcome set. The majority of stakeholders were from high-income countries. This study did not include stakeholders who did not speak English.

DISCLOSURES:

This study received support from the National Institute for Health and Care Research through a doctoral fellowship. Two authors reported receiving grant funding for stillbirth research.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.