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

Delphi study of pharmacology experts to derive international recommendations for medicine use in lactation

Lisa Amir, Clare Barnett; Kath Ryan, School of Nursing and Midwifery

Although most medicines are compatible with breastfeeding, pharmaceutical companies often state that a medicine is not recommended during lactation, leading to confusion amongst prescribing clinicians. Our objective was to gain international consensus on the key parameters experts use to inform decisions and to develop a user-friendly, evidence-based safety hierarchy for medicine use during breastfeeding.

We used a three-round web-based Delphi research design. Sixteen experts were identified based on their international prominence in the field, with a further 12 recruited through snowballing. Questionnaires were distributed electronically by a secure program (Qualtrics). Round 1 explored experts' opinions of current medicines and breastfeeding classification systems and identified key clinical, social and pharmacological parameters used to inform decisions. Rounds 2 and 3 built consensus around these parameters using a five-point Likert scale and prioritisation.

FUNDING: School of Nursing and Midwifery, La Trobe University, Healthy Motherhood Program Grant

STATUS: Results presented at conferences in 2014, one publication

PUBLICATION: Amir LH, Ryan K, Barnett C. Delphi survey of international pharmacology experts: an attempt to derive international recommendations for use of medicine in breastfeeding women. Breastfeed Med 2015; 10(3):168-74

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

MILC (Mothers and Infants Lactation Cohort): a multi-site study

Della Forster, Lisa Amir, Helen McLachlan, Anita Moorhead, Helene Johns; in collaboration with Rachael Ford, Royal Women's Hospital; Kerri McEgan, Mercy Hospital for Women

A high proportion of women in Australia initiate breastfeeding but many stop in the early months. Anecdotally expressing breast milk in hospital and after discharge home has increased. Little is known about the effect of early and longer-term breast milk expression on breastfeeding duration and on other factors such as maternal fatigue, stress and anxiety.

In this prospective cohort study exploring the frequency of breast milk expressing and the effect of expressing on breastfeeding outcomes and other factors, we recruited 1000 mothers of healthy term infants who planned to breastfeed from three hospitals (Mercy Hospital for Women, Frances Perry House and Royal Women's Hospital) prior to hospital discharge. The study involved completion of three structured interviews, face to face at recruitment and by telephone 3 and 6 months later. The primary outcome for comparison is feeding any breast milk at six months. Secondary outcomes included exclusive breastfeeding, maternal confidence and satisfaction with infant feeding. Breast pump uptake at recruitment and subsequent use was high. Early breastfeeding problems were common and less than half of the infants had fed only at the breast in the first days of life.

FUNDING: Faculty of Health Sciences Research Grant; PhD scholarship

STATUS: further analysis and writing‐up underway, five conference presentations in 2014

Forster DA, Johns HM, McLachlan HL, Moorhead AM, McEgan KM, Amir LH. Feeding infants directly at the breast during the postpartum hospital stay is associated with increased breastfeeding at 6 months postpartum: a prospective cohort study. BMJ Open 2015; 5:e007512

Johns H, Forster D, Amir LH, McLachlan H. Prevalence and outcomes of breast milk expressing in women with healthy term infants: a systematic review. BMC Pregnancy Childbirth 2013; 13: 212

Johns HM, Forster DA, Amir LH, Moorhead AM, McEgan KM, McLachlan HL. Infant feeding practices in the first 24–48 h of life in healthy term infants. Acta Paediatrica 2013; 102(7):e315-e20

Ringing Up about Breastfeeding – a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY)

Della Forster, Helen McLachlan, Mary-Ann Davey, Lisa Amir, Rhonda Small, Heather Grimes; in collaboration with Lisa Gold, Deakin University; Anita Moorhead and Fiona McLardie-Hore, Royal Women's Hospital; Chris East, Monash Health; Patrice Hickey, Sunshine Hospital; Nanette Shone and Kate Mortensen, Australian Breastfeeding Association; Cindy-Lee Dennis, University of Toronto, Canada

In Australia, although most women initiate breastfeeding, only about 60% are giving their infant any breast milk by six months. Furthermore, the gap in rates of breastfeeding between socially disadvantaged and advantaged infants has increased: less advantaged infants are much less likely to continue to be breastfed. Very few interventions have shown to increase breastfeeding maintenance in countries with high initiation of breastfeeding – peer support is one intervention that has shown some promise, but randomised trials have had mixed findings. The only one relevant to the Australian context demonstrated a positive outcome – a Canadian trial by Cindy-Lee Dennis – and it was this trial that formed the basis of our intervention. We received funding to conduct a trial of telephone support for breastfeeding provided by volunteer mothers who have themselves breastfed.

The trial is led jointly by a team from the Judith Lumley Centre and the Royal Women's Hospital, in collaboration with the Australian Breastfeeding Association, Monash Medical Centre and Sunshine Hospital. We use a two-arm randomised controlled trial to determine whether peer support, provided by telephone during the postnatal period using a proactive approach, increases the proportion of infants who are breastfed for at least six months. We are recruiting first-time mothers from postnatal wards of three Victorian hospitals whose catchments include areas with some of the lowest breastfeeding rates in the state.

  • Women randomised to the non-intervention arm receive usual hospital postnatal care and infant feeding support.
  • Women randomised to the intervention arm receive usual hospital postnatal care and infant feeding support as well as proactive peer support provided by telephone from a trained volunteer mother (who has breastfed for six months or more).

Training for the volunteer mothers is being conducted in conjunction with the Australian Breastfeeding Association. The peer support mothers are encouraged to provide most of the contact in the important early weeks, when many women cease breastfeeding, with continued contact tapering off up to six months postpartum. Outcome data will be collected at six months by telephone interview.

FUNDING: Felton Bequest; PhD Scholarship

STATUS: Training of volunteer mothers ongoing (115 trained by end of 2014); recruitment of participants began February 2013 (266 women to date); trial protocol paper submitted

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

RUBY website

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

Lisa Amir and Méabh Cullinane; in collaboration with Suzanne Garland and Sepehr Tabrizi, University of Melbourne; Susan Donath, Murdoch Childrens Research Institute; Catherine Bennett, Deakin University

This project is a descriptive study of 360 breastfeeding women, recruited from the Royal Women's Hospital and Frances Perry House. The aim of the study was to investigate the role of microorganisms in nipple and breast pain in breastfeeding women. At present, there is controversy about whether burning nipple pain associated with radiating breast pain is caused by fungal infection (Candida albicans, known as "thrush") or bacterial infection (Staphylococcus aureus, known as "golden staph").

For this study, at the time of recruitment, swabs were collected from mothers' noses, nipples and vagina and a questionnaire asking about previous staphylococcal and candida infections was completed. Following birth, the participating mothers were followed up six times: while still in hospital and then weekly at home until four weeks postpartum. At each of these follow-up meetings participants filled out a questionnaire and swabs were taken from the mother's nose and nipple as well as the baby's nose and mouth. Breast milk samples were also taken. At eight weeks postpartum a final telephone interview was held, collecting further information about breastfeeding problems such as nipple and breast pain.

The main outcomes paper was published in 2013 in BMJ Open. There was strong evidence of an association between the presence of Candida and nipple and breast pain, while Staphylococcus aureus was present in both women with and without pain.

FUNDING: NHMRC Health Professional Research Fellowship 2006-2010 (LA); NHMRC Project Grant 2009-2010; NHMRC Equipment Grant 2009-2010; Helen Macpherson Smith 2011-2012 STATUS: Recruiting completed; protocol published; main outcomes paper published in 2013; further analysis and dissemination underway

STATUS: Recruiting completed; protocol published; main outcomes paper published in 2013; further analysis and dissemination underway

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

CASTLE website

Rural and city design workshops to promote breastfeeding in public

Lisa Amir, Helene Johns; in collaboration with Julie Rudner, Community Planning and Development, La Trobe University, Bendigo; Deborah Remfry, urban planner; Kelly Adams, urban designer; Susan Tawia, Breastfeeding Information and Research, Australian Breastfeeding Association

Although the right to breastfeed in public has been established by law in Australia, the general public may not be aware of this, and prudishness about seeing a baby at the breast can lead waiters, security guards, and others to respond inappropriately when women breastfeed in "their space". This interdisciplinary – planning and health – approach aims to make public spaces more welcome and inclusive for breastfeeding women.

FUNDING: Building Healthy Communities RFA Grant

STATUS: Project commenced August 2015

Supporting breastfeeding In Local Communities (SILC)

Helen McLachlan, Della Forster, Lisa Amir, Rhonda Small, Méabh Cullinane, Touran Shafiei, Lyn Watson, Rhian Cramer in collaboration with Lael Ridgway, School of Nursing and Midwifery, La Trobe University

Breastfeeding provides infants with the optimal start to life, yet despite recommendations from the World Health Organization and high rates of breastfeeding initiation, exclusive breastfeeding for six months is uncommon in Australia. Increased breastfeeding support early in the postpartum period may improve breastfeeding maintenance.

The Department of Education and Early Childhood Develop­ment (DEECD) provided funding to trial interventions aimed at increasing breastfeeding duration in Local Government Areas (LGAs) in Victoria. This trial is a three-arm cluster randomised controlled trial evaluating whether two specific community-based interventions increase breast­fee­ding maintenance in Victorian LGAs. Ten LGAs with a lower than average rate of any breastfeeding at hospital discharge and more than 450 births per year that agreed to participate were randomly allocated to one of three trial arms:

  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.

Home visits were conducted by experienced Maternal and Child Health Nurses (SILC-MCHNs). Breastfeeding drop-in centres were staffed by SILC-MCHNs. The interventions ran for a nine-month period from July 2012 to March 2013.

The primary outcome is the proportion of infants receiving any breast milk at four months of age. The secondary outcomes are the proportion of infants receiving any breast milk at three months and six months; the exploration of early breastfeeding problems and women's satisfaction with breastfeeding support; the investigation of SILC-MCHN and MCH co-ordinator satisfaction with SILC; and the comparison of pre-intervention and post-intervention breastfeeding rates in each LGA. Breastfeeding outcomes were obtained from routinely collected Maternal and Child Health (MCH) centre data, including a new question collecting infant feeding 'in the last 24 hours'. Information was also obtained directly from women via a postal survey when their infants were six months of age.

FUNDING: DEECD 2011-2014

STATUS: Final report submitted to DEECD; trial protocol published; primary outcomes paper submitted

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

SILC website