Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial

摘要: Summary Background Infants of women with diabetes in pregnancy are at increased risk hypoglycaemia, admission to a neonatal intensive care unit (NICU), and not being exclusively breastfed. Many clinicians encourage express store breastmilk late pregnancy, yet no evidence exists for this practice. We aimed determine the safety efficacy antenatal expressing pregnancy. Methods did multicentre, two-group, unblinded, randomised controlled trial six hospitals Victoria, Australia. recruited pre-existing or gestational singleton from 34 37 weeks' gestation randomly assigned them (1:1) either twice per day 36 (antenatal expressing) standard (usual midwifery obstetric care, supplemented by support educator). Randomisation was done computerised random number generator blocks size two four, stratified site, parity, type. Investigators were masked block but masking caregivers possible. The primary outcome proportion infants admitted NICU. analyses intention treat; data obtained analysed group allocation. This is registered Australian New Zealand Clinical Trials Registry, ACTRN12611000217909. Findings Between June 6, 2011, Oct 29, 2015, we 635 women: 319 316 care. Three included analysis (one withdrawal group, one post-randomisation exclusion group). NICU differ between groups (46 [15%] 317 vs 44 [14%] 315 care; adjusted relative 1·06, 95% CI 0·66 1·46). In most common serious adverse event respiratory (for three [ Interpretation There harm advising low complications gestation. Funding National Health Medical Research Council.