A pragmatic stepped wedge cluster randomised implementation trial assessing the effect of a quality improvement programme on the proportion of infants achieving delayed cord clamping for more than 60 seconds in infants <37 weeks gestation: Statistical analysis plan for the Wait a Minute or More (WAMM) trial

Abstract The Wait a Minute or More (WAMM) trial is a pragmatic stepped-wedge cluster randomised implementation trial designed to increase the proportion of preterm infants receiving delayed cord clamping for at least 60 seconds (DCC60) across Australian maternity hospitals. This statistical analysis plan prespecifies primary, secondary, and exploratory analyses prior to accessing outcome data. The primary analysis will use mixed-effects modelling to estimate the effect of a locally adapted quality improvement programme and accurate data sharing, on achieving DCC60, accounting for clustering and secular trends. By detailing our approach, this SAP ensures transparency, reproducibility, and rigorous evaluation of the WAMM intervention.