Introduction and objectives: Despite limited evidence, many midwives, lactation consultants, doctors, endocrinologists and diabetes educators recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy for use after birth to treat neonatal hypoglycaemia, thereby promoting early lactogenesis and exclusive breast milk feeding. The DAME trial investigated the safety and efficacy of this increasingly widespread practice.
Method: A two-arm, multi-centre, RCT was conducted. Women were randomised at 36 to 37 weeks gestation to standard care, or to twice daily hand expressing of breast milk for 10 minutes until birth. All study sites agreed there would be no advice to women to express outside the trial. Randomisation was stratified by site, parity and diabetes type. The study was powered to detect a 10% difference in the proportion of babies admitted to special or neonatal intensive care (the primary outcome). Secondary perinatal outcomes included gestation at birth, proportion of infants receiving exclusive breast milk during their hospital stay related to the birth, and women’s views. Analyses are by intention to treat.
Results: A total of 635 women were randomised to the trial, the last on 29/10/2015. Results to be presented will include the rate of admission to special or intensive care for babies, rate of exclusive breastfeeding in hospital and three months, gestation at birth and volume of antenatal milk produced. Extensive data have been collected to assess safety related to expressing, and the trial Safety Committee had no concerns.
Conclusions: This is the first RCT to test the widespread practice of antenatal milk expression. The results will inform clinical practice and are keenly awaited both nationally and internationally.