Aims: To develop a core outcome set for trials investigating interventions to prevent stillbirth. Materials & Methods: Outcomes identified from a systematic literature review and semi-structured interviews with parents in Australia and the UK were entered into a two-round online 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, onset of and mode of delivery, maternal mortality or near miss, psychological and social impact on the women, women's knowledge. Six outcomes were related to the baby; timing of stillbirth, neonatal mortality, gestational age at delivery, birthweight, congenital anomaly, NICU/SCBU or other higher-level neonatal care length of stay. Conclusions: 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.Contributors
Kim B.V., Aromataris E.C., Middleton P., Townsend R.,Thangaratinam S., Duffy J.M.N., de Lint W., Coat S., Flenady V., Khalil A., Mol B.W.
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Systematic review
1. Conduct a systematic review of outcome measures used in studies evaluating stillbirth prevention to identify reported outcomes.
2. Run a focus group/interviews with parents who have suffered stillbirth to identify outcomes important to them
3. Using the identified outcomes from step 1 and 2 and develop an outcome inventory to be used in Delphi survey
4. Use Delphi method to reach consensus on elements of the inventory with the involvement of all stakeholders.
5. Determine how the outcomes should be defined and measured with consultations with stakeholders.