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
SuDDICU Protocol
