Main analysis
RECRUITMENT
Our primary outcome (overall recruitment rate as a percentage of eligible women) will be estimated within 10% of the true value or better using the Clopper-Pearson exact Binomial method for a 95% confidence interval. The number of women screened, eligible, consented, randomised and withdrawn from the study will be reported by site, and overall numbers summarised as a CONSORT flow diagram. Reasons for exclusion and for withdrawal will be summarised. Adherence to the intervention will be assessed by the number of SPEBTs received by women randomised to the intervention arm and will be presented in the CONSORT flow diagram.Descriptive statistics including 95% confidence intervals will be presented for all baseline data and clinical outcomes, with a focus on estimates of standard deviation necessary to perform sample size calculations for a future trial.Although the study is expected to be underpowered for clinical outcomes, the differences in the clinical outcomes will be presented as an initial assessment of the efficacy and safety of this treatment, and for inclusion in any future meta-analysis. Clinical outcomes will be analysed using a complete case analysis approach. No subgroup analyses are planned.We plan to conduct a single analysis at the end of data collection. A set of dummy tables for all feasibility and clinical outcomes are provided in Additional file 