Economic evaluation Resource use data will be collected from the

Economic evaluation Resource use data will be collected from the medical record following birth and from women’s self-reported use of health care and other resources in the 12 weeks after the birth. Costs included in the economic evaluation are those relating to care provided by the hospital (including admission to SCN/NICU) and women’s (infants’) things use of healthcare and other societal resources over the period of the evaluation. Measured resource use will be valued using existing unit cost estimates (eg, Diagnosis Related Groups cost weights for hospital admissions for mother and infant48 and Medicare fee schedules for any attendances at

the women’s local doctor).49 As the primary outcome measure is itself a resource use item, economic evaluation will be expressed as cost-effectiveness analysis against exclusive breastfeeding at 3 months. Blinding: The nature of the trial necessitates non-blinding of participants assigned to the intervention group, so that staff know to look

for expressed breast milk in the freezer if it is available and required, and at most sites both the intervention and control groups need to be non-blinded to ensure that point of care TBGs are performed rather than BSLs, as most sites do BSLs unless indicated (rather than the TBGs required by this trial). Staff at sites that routinely undertake TBGs for all infants of women with diabetes in pregnancy will be blinded to women in the control group. Abstraction of medical record data will be undertaken blinded to group allocation; data will be presented to the data monitoring committee for the interim analysis in unlabelled study groups; and the research team will remain blinded to group allocation at all stages prior to final data analysis. Data analysis Data will be collected to meet the CONSORT guidelines for reporting of randomised trials,50 including data on eligible non-participants. The first stage of analysis will check the comparability of participants allocated to the two groups. The intervention group will be compared with the standard care group by intention to treat analysis. The primary

outcome measure GSK-3 will be compared using χ2 tests and ORs. Comparison of means will be undertaken for continuous variables using t tests where data are normally distributed or Mann-Whitney U tests will compare medians otherwise. Ranked or Likert-type scales will be analysed using cumulative ORs. Where there are differences in baseline characteristics of the women in the two groups which might be associated with outcomes, an additional multivariate analysis will be carried out. Duration of breastfeeding will be compared using Kaplan-Meier statistics. Content analysis will be used to summarise open-ended comments.51 Data and Safety Monitoring Committees: A Data Monitoring Committee including a statistician, a midwife and an obstetrician (experienced in conducting RCTs) will undertake an interim analysis after half the women have given birth.

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