Development of a core outcome set for interventions to prevent
stillbirth: a multi-stakeholder Delphi consensus study
Abstract
Abstract Objective: To develop a core outcome set for trials
investigating interventions to prevent stillbirth. Design Outcomes
identified from a systematic literature review and semi-structured
interviews with parents were entered into a two-round online Delphi
survey. Setting and population Australia and UK Methods: Delphi survey
and focus group/consensus meetings Results: A core outcome set
containing 11 outcomes in two categories. Five outcomes were related to
the mother; fetal loss (to include both miscarriage and stillbirth),
onset of and mode of delivery (to include induced/spontaneous and
instrumental/vaginal/CS), maternal mortality or near miss (according to
WHO definition), psychological and social impact on the mother (assessed
using a validated tool appropriate to context), women’s knowledge. Six
outcomes were related to the baby; timing of stillbirth
(antepartum/intrapartum), neonatal mortality, gestational age at
delivery, birthweight (g), congenital anomaly, NICU/SCBU or other
higher-level neonatal care length of stay (days). Conclusion
Implementation and dissemination of this core outcome set in future
trials will contribute towards coordinated outcome reporting and
advancing usefulness of research to guide clinical practice. Keywords:
Core outcomes, core outcome set, Stillbirth, Delphi