title: Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.
abstract: BACKGROUND
  Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.
  
  
  METHODS
  Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview).
  
  
  METHODS
  the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ(2) and ORs.
  
  
  BACKGROUND
  Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants.
  
  
  BACKGROUND
  Australian Controlled Trials Register ACTRN12611000217909.
authors.affiliation: Judith Lumley Centre (formerly Mother & Child Health Research), La Trobe University, Melbourne, Victoria, Australia.|Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Della A
authors.initials: DA
authors.lastname: Forster
authors.affiliation: Royal Women's Hospital, Parkville, Victoria, Australia.|Clinical Sciences, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.|Department of Obstetrics and Gynaecology, University of Melbourne, Carlton, Victoria, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Jacobs
authors.affiliation: Judith Lumley Centre (formerly Mother & Child Health Research), La Trobe University, Melbourne, Victoria, Australia.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Amir
authors.affiliation: Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Davis
authors.affiliation: Department of Obstetrics and Gynaecology, University of Melbourne, Carlton, Victoria, Australia.|Mercy Hospital for Women, Heidelberg, Victoria, Australia.
authors.forename: Susan P
authors.initials: SP
authors.lastname: Walker
authors.affiliation: Mercy Hospital for Women, Heidelberg, Victoria, Australia.
authors.forename: Kerri
authors.initials: K
authors.lastname: McEgan
authors.affiliation: Department of Obstetrics and Gynaecology, University of Melbourne, Carlton, Victoria, Australia.|Mercy Hospital for Women, Heidelberg, Victoria, Australia.
authors.forename: Gillian
authors.initials: G
authors.lastname: Opie
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Donath
authors.affiliation: Judith Lumley Centre (formerly Mother & Child Health Research), La Trobe University, Melbourne, Victoria, Australia.|Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Anita M
authors.initials: AM
authors.lastname: Moorhead
authors.affiliation: Judith Lumley Centre (formerly Mother & Child Health Research), La Trobe University, Melbourne, Victoria, Australia.|Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Rachael
authors.initials: R
authors.lastname: Ford
authors.affiliation: Mercy Hospital for Women, Heidelberg, Victoria, Australia.
authors.forename: Catharine
authors.initials: C
authors.lastname: McNamara
authors.affiliation: Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Aylward
authors.affiliation: Deakin Health Economics, Deakin University, Burwood, Victoria, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Gold
mesh_terms: D000328:Adult; D001942:Breast Feeding; D061186:Breast Milk Expression / Q000379:methods*; D016640:Diabetes, Gestational; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology / Q000628:therapy*; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000209:etiology / Q000628:therapy*; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data*; D007774:Lactation; D011247:Pregnancy; D011254:Pregnancy in Diabetics; D011295:Prenatal Care / Q000379:methods; D016896:Treatment Outcome
keywords: NEONATOLOGY; NUTRITION & DIETETICS