Full title: My Baby’s Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

Abstract

Objective The My Baby’s Movements (MBM) trial aimed to evaluate the\nimpact on stillbirth rates of a multifaceted awareness package (MBM\nintervention). Design Stepped-wedge cluster-randomised controlled trial.\nSetting Twenty-seven maternity hospitals in Australia and New Zealand.\nPopulation Women with a singleton pregnancy without major fetal anomaly\n≥28 weeks’ gestation from August 2016-May 2019. Methods The MBM\nintervention was implemented at randomly assigned time points with\nsequential introduction into 8 clusters of 3-5 hospitals at four-monthly\nintervals. The stillbirth rate was compared in the control and\nintervention periods. Generalised linear mixed models controlled for\ncalendar time, clustering, and hospital effects. Outcome Measures\nStillbirth at ≥28 weeks’ gestation. Results There were 304,853 births\nwith 290,219 meeting inclusion criteria: 150,079 in control and 140,140\nin intervention periods. The stillbirth rate during the intervention was\nlower than the control period (2.2/1000 births versus 2.4, odds ratio\n[OR] 0.91, 95% Confidence Intervals [CI] 0.78-1.06, p=0.22).\nThe decrease was larger across calendar time with 2.7/1000 in the first\n18 months versus 2.0/1000 in the last 18 months (OR 0.74; 95% CI\n0.63-0.86; p≤0.01). Following adjustment, stillbirth rates between the\ncontrol and intervention periods were not significantly different: (aOR\n1.18, 95% CI 0.93-1.50; p=0.18). No increase in secondary outcomes,\nincluding obstetric intervention or adverse neonatal outcome, was\nevident. Conclusion The MBM intervention did not reduce stillbirths\nbeyond the downward trend over time, suggesting hospitals may have\nimplemented best practice in DFM management outside their randomisation\nschedule. The role of interventions for raising awareness of DFM remains\nunclear