Diabetes and antenatal milk expressing (DAME): a randomised controlled trial

Della Forster, Lisa Amir, Anita Moorhead; in collaboration with Susan Jacobs and Peter Davis, Royal Women's Hospital; Susan Walker, Kerri McEgan and Gillian Opie, Mercy Hospital for Women; Susan Donath, Murdoch Childrens Research Institute; Rachael Ford, Royal Women's Hospital; Catherine McNamara, Mercy Hospital for Women; Amanda Aylward, Royal Women's Hospital; Christine East, Monash Medical Centre; Lisa Gold, Deakin University

Diabetes is increasing globally and occurs in 8% of pregnancies. These pregnancies are considered to be at high risk of perinatal complications. Infants of women with diabetes in pregnancy have an increased risk of developing diabetes and being obese later in life, and are highly likely to be exposed to cow's milk protein early, also increasing the risk of diabetes. Many maternity providers encourage these 'high-risk' women to express colostrum before birth to have breast milk available should the infant need supplementary feeding to treat hypoglycaemia.

Pilot data from our group and another small study in the United Kingdom found increased special care nursery (SCN) admissions in infants of mothers who expressed antenatally, and the UK study found a one-week reduction in pregnancy gestation. Evidence for this practice is lacking so we are undertaking a multi-site, two-arm randomised controlled trial (RCT) of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy to explore the safety and efficacy for mother, fetus and infant. The trial sites are the Mercy Hospital for Women, the Royal Women's Hospital, the Women's at Sandringham, Monash Medical Centre, Geelong Hospital, (Barwon Health), and Frankston Hospital (Peninsula Health).

The primary hypothesis of this study is that infants of women with diabetes in pregnancy, who commence antenatal expressing of colostrum from 36 weeks' gestation, will be more likely to be admitted to the SCN/NICU after birth compared with infants of women with diabetes in pregnancy that receive standard care. We will also test whether antenatal expressing increases the proportion of infants receiving exclusive breast milk during the hospital stay after the birth and at three months of age, and whether it decreases duration of pregnancy. We are in the process of recruiting 658 women to the study.

FUNDING: NHMRC project grant 2011-2014

STATUS: Recruitment underway (565 women recruited), Higher Degree (Research) candidate enrolled

Forster DA, Jacobs SE, Amir LH, Davis P, Walker SP, McEgan K, Opie G, Donath SM, Moorhead AM, Ford R, McNamara C, Aylward A, Gold L. Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial. BMJ Open 2014; 4:e006571

Forster D. Changing attitudes. International Innovation, Health Partnership 2012;Dec:82-4 [PDF 312KB]

Forster DA, McEgan K, Ford R, Moorhead A, Opie G, Walker S, McNamara C. Diabetes and antenatal milk expressing: a pilot project to inform the development of a randomised controlled trial. Midwifery 2011;27(2):209-14

DAME websites

Improving maternity care and breastfeeding outcomes for Aboriginal mothers and babies in Victoria

Helen McLachlan, Lisa Amir, Della Forster, Michelle Newton, Kate Dawson, Touran Shafiei; in collaboration with Karen Adams, Victorian Aboriginal Community Controlled Health Organisation (VACCHO); Helena Maher, Teagan Cornelissen, Royal Women's Hospital
Partners: Victorian Aboriginal Community Controlled Health Organisation (VACCHO); The Royal Women's Hospital

Breastfeeding provides many benefits for babies and children. Aboriginal women in urban areas are less likely to initiate breastfeeding compared with non-Aboriginal women and the proportion of Aboriginal babies being predominantly breastfed at six months is half the rate of non-Indigenous babies (17% vs 35%). These data point to the need for further research on why Aboriginal women stop breastfeeding (or do not start), and how they can be supported to continue.

A recent report by the Victorian Aboriginal Community Controlled Health Organisation (VACCHO) identified breastfeeding as a key concern and recommended planning, implementing and evaluating strategies to improve breastfeeding rates for Aboriginal women. The recommendation is consistent with a number of government inquiries and reviews. In partnership with VACCHO, we are exploring a number of strategies that may help increase breastfeeding rates among Aboriginal women in Victoria, including gaining an understanding of the breastfeeding rates in different parts of Victoria using routinely collected data and exploring the feasibility of implementing models of maternity care that provide continuity of midwife care.

FUNDING: Building Healthy Communities RFAGrant; Healthy Motherhood Program Grant

STATUS: Data collection in progress, paper drafted

The role of micro-organisms (S. aureus & C. albicans) in the pathogenesis of breast pain and infection in lactating women (CASTLE Study)

researchers Lisa Amir, Méabh Cullinane; in collaboration with Suzanne Garland and Sepehr Tabrizi, Bio21 Molecular Science & Biotechnology, University of Melbourne; Susan Donath, Murdoch Children’s Research Institute; Catherine Bennett, Deakin University
description This project is a descriptive study of 360 breastfeeding women, recruited from the Royal Women’s Hospital and Frances Perry House. The aim was to investigate the role of microorganisms in nipple and breast pain in breastfeeding women. Secondary outcomes were maternal physical and mental health in the first eight weeks postpartum.
funding NHMRC Health Professional Research Fellowship (LA); NHMRC Project Grant; NHMRC Equipment Grant; Helen Macpherson Smith
status Primary outcomes published in BMJ Open in 2013, one paper published in 2017, two more papers submitted
  • Cooklin AR, Amir LH, Nguyen CD, Buck ML, Cullinane M, Fisher JRW, Donath SM, the CASTLE Study Team. Physical health, breastfeeding problems and maternal mood in the early postpartum: a prospective cohort study. Arch Womens Ment Health 2018; 21(3):365–74.
  • Buck ML, Amir LH, Cullinane M, Donath SM, for the CASTLE Study Team. Nipple pain, damage and vasospasm in the first 8 weeks postpartum. Breastfeed Med 2014; 9(2):56-62
  • Amir LH, Donath SM, Garland SM, Tabrizi SN, Bennett CM, Cullinane M, Payne MS. Does Candida and/or Staphylococcus play a role in nipple and breast pain in lactation? A cohort study in Melbourne, Australia. BMJ Open 2013; 3(3): e002351
  • Amir LH, Cullinane M, Garland SM, Tabrizi SN, Donath SM, Bennett CM, Cooklin AR, Fisher JR, Payne MS. The role of micro-organisms (Staphylococcus aureus and Candida albicans) in the pathogenesis of breast pain and infection in lactating women: study protocol. BMC Pregnancy Childbirth 2011; 11: 54
websiteCASTLE website

RUBY (Ringing up about breastfeeding early): Proactive peer (mother-to-mother) breastfeeding support by telephone

researchers Della Forster, Lisa Amir, Helen McLachlan, Touran Shafiei, Rhonda Small, Fiona McLardie-Hore, Heather Grimes; in collaboration with Anita Moorhead, Royal Women’s Hospital; Mary-Ann Davey, Christine East, Monash University; Cindy-Lee Dennis, University of Toronto; Lisa Gold, Deakin University; Kate Mortensen and Susan Tawia, Australian Breastfeeding Association
description The RUBY (Ringing Up about Breastfeeding earlY) study aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. RUBY was a multicentre, randomised controlled trial conducted in three hospitals in Victoria, between February 2013 and December 2015.
Over 1150 first-time mothers intending to breastfeed were recruited at one of the three hospitals (Royal Women’s, Monash Health, Western Health Sunshine) after birth and prior to hospital discharge. They were randomly assigned to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum.
The study found that infants of women allocated to telephone-based peer support were more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%).
funding The Felton Bequest, Australia and La Trobe University
status Main outcomes paper submitted
  • Forster DA, McLardie-Hore FE, McLachlan HL, Davey M-A, Grimes HA, Dennis C-L, Mortensen K, Moorhead AM, Tawia S, Gold L, Shafiei T, Small R, East CE, Amir LH. Proactive peer (mother-to-mother) breastfeeding support by telephone (Ringing Up about Breastfeeding EarlY [RUBY]): A multicentre, unblinded, randomised controlled trial. EClinicalMedicine (in press). Epub 2019 Mar 05
  • Forster DA, McLachlan HL, Davey MA, Amir LH, Gold L, Small R, Mortensen K, Moorhead AM, Grimes H, McHardie-Lore F. Ringing Up about Breastfeeding: A randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) - trial protocol. BMC Pregnancy Childbirth 2014; 14:177
websiteRuby website

Supporting breastfeeding In Local Communities (SILC)

researchers Helen McLachlan, Della Forster, Lisa Amir, Rhonda Small, Méabh Cullinane, Touran Shafiei, Lyn Watson, Rhian Cramer, Lael Ridgeway
description Breastfeeding provides infants with the optimal start to life.  However, exclusive breastfeeding for six months is uncommon in Australia. Increased breastfeeding support early in the postpartum period may improve breastfeeding maintenance.
With funding from the Victorian Department of Education and Early Childhood Development, we conducted a three-arm cluster trial evaluating two community-based interventions aimed at increasing breastfeeding rates in 10 Victorian Local Government Areas.
The trial arms were: 1) standard care; 2) early postnatal home-based breastfeeding support visits to women at risk of breastfeeding cessation, or 3) home-based breastfeeding support visits plus access to community-based breastfeeding drop-in centres.
We found no difference in breastfeeding maintenance at three, four or six months in either the home visit or home visit plus drop-in compared with the comparison arm. Early home-based and community-based support proved difficult to implement. Interventions to increase breastfeeding in complex community settings require sufficient time and partnership building for successful implementation.
funding Victorian Department of Education and Early Childhood Development
status Final report submitted; protocol, primary outcomes and two other papers published, other papers in preparation
  • McLachlan HL, Forster DA, Amir LH, Cullinane M, Shafiei T, Watson LF, Ridgway L, Cramer RL, Small R. Supporting breastfeeding In Local Communities (SILC) in Victoria, Australia: a cluster randomised controlled trial. BMJ Open 2016; 6:e008292
  • Ridgway L, Cramer R, McLachlan HL, Forster DA, Cullinane M, Shafiei T, Amir LH. Breastfeeding support in the early postpartum: Content of home visits in the SILC trial. Birth 2016; 43(4):303-12
  • McLachlan HL, Forster DA, Amir LH, Small R, Cullinane M, Watson LF, Shafiei T. Supporting breastfeeding In Local Communities (SILC): protocol for a cluster randomised controlled trial. BMC Pregnancy Childbirth 2014; 14:346
  • McLachlan H, Forster D, Amir LH, Small R, Cullinane M, Shafiei T, Cramer R, Ridgeway L. The Victorian Breastfeeding Project Phase Two: SILC final report. Melbourne, Australia: Judith Lumley Centre, La Trobe University; July 2014
websiteSILC website

Understanding community attitudes and identifying design solutions to increase women’s comfort with breastfeeding in public

researchers Lisa Amir, Stephanie Amir, Helene Johns; in collaboration with Julie Rudner, La Trobe University; Jenny Donovan, Inclusive Design; Miranda Buck, Australian Breastfeeding Association; Sinead Currie and Pat Hoddinott, University of Stirling
description This project explores design features and community attitudes that invite or deter breastfeeding in public.  We conducted interviews and focus groups with breastfeeding mothers in three local government areas in 2016 (Rural City of Swan Hill, City of Greater Bendigo and City of Melbourne) and at The Royal Women’s Hospital in 2018.
We received input from over 80 mothers speaking five languages, as well as health professionals and council planning staff. Using these data, we have developed design guidelines that outlined how a range of everyday shared spaces could become breastfeeding-friendly as well as the optimal design characteristics for dedicated breastfeeding spaces.
funding Building Healthy Communities RFA Grant
status Papers in preparation