Background A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which has been identified as an important research priority. Objectives To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. Search strategy Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. Selection criteria Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. Data collection and analysis Interventions, outcomes reported, definitions and outcome measurement tools were extracted. Main results 40 randomised and 200 non-randomised studies were included. 58 different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. 242 outcome measurement instruments were used, with 0-22 tools per outcome. Conclusions Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.

Objective To quantify parents’ experiences of respectful care around stillbirth globally. Design Multi-country, online, cross-sectional survey. Setting and Population Self-identified bereaved parents (n=3769) of stillborn babies from 44 high- and middle-income countries. Methods Parents’ perspectives of 7 aspects of care quality, factors associated with respectful care, and 7 bereavement care practices were compared across geographical regions using descriptive statistics. Respectful care was compared between country income groups using multivariable logistic regression. Main Outcome Measures Self-reported experience of care around the time of stillbirth Results A quarter (25.4%) of 3769 respondents reported disrespectful care after stillbirth and 23.5% reported disrespectful care of their baby. Gestation <30 weeks, and primiparity were associated with disrespect. Reported respectful care was lower in middle-income countries (MICs) than in high-income countries (HICs) (aOR=0.35, 95%CI (0.29-0.42), p <0.01). In many countries, aspects of care quality need improvement, such as ensuring families have enough time with providers. Participating respondents from Latin America and Southern Europe reported lower satisfaction across all aspects of care quality compared to Northern Europe. Unmet need for memory-making activities in MICs is high. Conclusions Despite improvements, many parents still experience disrespectful care around stillbirth. The gap between parents’ access to memory-making activities in MICs and HICs needs urgent attention. Tweetable abstract A quarter of parents of stillborn babies experience disrespectful care. There is global unmet need for memory-making activities

Objective The My Baby’s Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (MBM intervention). Design Stepped-wedge cluster-randomised controlled trial. Setting Twenty-seven maternity hospitals in Australia and New Zealand. Population Women with a singleton pregnancy without major fetal anomaly ≥28 weeks’ gestation from August 2016-May 2019. Methods The MBM intervention was implemented at randomly assigned time points with sequential introduction into 8 clusters of 3-5 hospitals at four-monthly intervals. The stillbirth rate was compared in the control and intervention periods. Generalised linear mixed models controlled for calendar time, clustering, and hospital effects. Outcome Measures Stillbirth at ≥28 weeks’ gestation. Results There were 304,853 births with 290,219 meeting inclusion criteria: 150,079 in control and 140,140 in intervention periods. The stillbirth rate during the intervention was lower than the control period (2.2/1000 births versus 2.4, odds ratio [OR] 0.91, 95% Confidence Intervals [CI] 0.78-1.06, p=0.22). The decrease was larger across calendar time with 2.7/1000 in the first 18 months versus 2.0/1000 in the last 18 months (OR 0.74; 95% CI 0.63-0.86; p≤0.01). Following adjustment, stillbirth rates between the control and intervention periods were not significantly different: (aOR 1.18, 95% CI 0.93-1.50; p=0.18). No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. Conclusion The MBM intervention did not reduce stillbirths beyond the downward trend over time, suggesting hospitals may have implemented best practice in DFM management outside their randomisation schedule. The role of interventions for raising awareness of DFM remains unclear

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