Development of a core outcome set for interventions to prevent stillbirth.

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.

Developing a core outcome set in interventions to prevent stillbirth: A systematic review on variations of outcome reporting.

OBJECTIVE: To determine which outcomes have been previously reported in previous stillbirth prevention studies. RESEARCH DESIGN: Systematic review of reviews: We searched the Cochrane Database of Systematic Reviews, EMBASE and Pubmed for systematic reviews and meta- analyses investigating interventions to prevent stillbirth and its major risk factors. DATA COLLECTION AND ANALYSIS: Two reviewers identified and extracted outcomes independently. Outcomes were categorised under relevant domains for analysis. Frequency of each outcome was also determined. MAIN RESULTS: From 51 eligible reviews, 16 reviews addressed stillbirth prevention specifically while 35 reviews evaluated the efficacies of prevention or management of the eight major risk factors of stillbirth. Two hundred and thirty-seven outcomes were extracted, including 150 maternal outcomes and 87 offspring outcomes. Stillbirth (35/51), perinatal mortality (34/51) and neonatal mortality (33/51) were the most commonly reported outcomes followed by birthweight (29/51), caesarean section (28/51) and preeclampsia/eclampsia (23/51). Self-reported mother/family focused outcomes on their experiences and views were reported in 10/51 reviews. CONCLUSION: In studies evaluating prevention of stillbirth there is a large variety in outcomes, with discrepancies in nomenclature and measurements. Woman/family-centred outcomes are often missing from studies. There is a need for a core outcome sets agreed by all stakeholders containing the recommended minimum data to be reported in future studies investigating prevention of stillbirth.