My Baby's Movements: A Stepped-Wedge Cluster-Randomised Controlled Trial of a Fetal Movement Awareness Intervention to Reduce Stillbirths

Background: Maternal perception of decreased fetal movements (DFM) is associated with stillbirth. The My Baby’s Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package for women and clinicians. Methods: A stepped wedge cluster randomised controlled trial was undertaken with 8 groups of 3-5 hospitals in Australia and New Zealand at four-monthly intervals, targeting women with a singleton pregnancy without major fetal anomaly at ≥28 weeks’ gestation. The primary outcome was stillbirth at ≥28 weeks’ gestation. Secondary outcomes included obstetric and neonatal outcomes. Analysis was undertaken using generalised linear mixed models controlling for calendar time, clustering, and hospital effects. Findings: From August 2016 to May 2019 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, although not statistically significant (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). Adjusting for calendar time, 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 obstetric intervention or adverse neonatal outcome was evident. Interpretation: 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. Based on these findings, the role of interventions for raising awareness of DFM remains unclear. Trial Registration: ACTRN12614000291684. Funding Statement: National Health and Medical Research Council (NHMRC) Project Grant Application (APP1067363). Stillbirth Foundation Australia provided funding to develop the MBM application. Dr Glenn Gardener was provided a Betty McGrath Fellowship through the Mater Research Institute. Additional support was provided by Mater Foundation and the NHMRC Stillbirth Centre of Research Excellence. Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: Primary ethics approval was obtained from Mater Misericordiae Ltd Human Research Ethics Committee (EC00332) (MML HREC) in 2015. Further jurisdictional ethics approval was obtained from seven participating HRECs include the ACT Health, Northern Sydney Local Health District (NSLHD), Northern Territory Department of Health and Menzies School of Health Research, The Central Health and Disability Ethics Committee (NZ), Melbourne Health, and the Mercy Health. Governance clearance was obtained from all 26 sites involved in the trial.