Standard care All women with pre-existing or GDM are seen by a diabetes educator for management of their diabetes. Additionally, all women discuss breastfeeding with midwives during U0126 buy pregnancy, and at all sites women can ask to see a lactation consultant in the antenatal period if they wish. No site can participate in the
trial if they recommend that women express colostrum in the antenatal period. Management of neonatal hypoglycaemia The intervention being tested is not aimed at preventing hypoglycaemia; however, in practice the aim of many clinicians who advise antenatal milk expressing for this group is to avoid the use of formula for supplementary feeding if/when neonatal hypoglycaemia occurs. Based on our pilot data, approximately half of the admissions to SCN or NICU will be for neonatal hypoglycaemia.43 We will measure the incidence and duration of neonatal hypoglycaemia; however, it is not expected that encouraging women to express prior to birth could of itself prevent neonatal hypoglycaemia. Existing guidelines for management of newborn infants at risk
of hypoglycaemia, including infants of women with diabetes in pregnancy, will be followed. While there may be slight variations in guidelines by trial site, for the purposes of data analysis neonatal hypoglycaemia is defined as a true blood glucose (TBG) <2.6 mmol/L as measured on a blood gas analyser (or portable point of care TBG analyser) or in the laboratory. Sites whose guidelines for management of newborn infants
at risk of hypoglycaemia are too different from this are not eligible to participate in the trial, and site guidelines are reviewed by the trial neonatologist prior to a decision about any site’s suitability for inclusion. Although bedside testing with a glucometer is possible (providing BSLs), this method is not accurate at low blood glucose levels, when a TBG is mandatory. Prompt, standardised and accurate blood glucose measurement of TBG is optimal,46 47 and in the trial will eliminate measurement bias in either trial arm. A portable point of care TBG analyser will facilitate prompt, accurate TBG measurement at the bedside without separation of mother and baby—crucial in supporting early breastfeeding. Stratification by site ensures that any slight variation in infant glucose management will not Entinostat affect trial outcomes. Regardless of group assignment, mothers will breastfeed their infants, and express their milk postpartum if required. The first response to hypoglycaemia (as per existing clinical guidelines at the two primary trial sites, RWH and MHW) is a prescribed volume (30–60 mL/kg/day of supplemental feed of expressed breast milk or infant formula, or glucose gel (0.5 mL/kg of 40%)) massaged into buccal mucosa.