Diabetes is increasing globally and occurs in 8% of pregnancies. These pregnancies are considered to be at high risk of perinatal complications. Many maternity providers encourage these women to express colostrum before birth to have breast milk available should the infant need supplementary feeding to treat hypoglycaemia. Evidence for this practice is lacking.
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 sites are the Mercy Hospital for Women, the Royal Women's Hospital, Monash Medical Centre, Barwon Health, the Royal Women's at Sandringham, and Frankston Hospital. We commenced recruiting women for the trial in June 2011 and finished recruiting in November 2015.
DAME Trial Newsletters for staff at participating hospitals:
Newsletter No 1 - February 2012 [PDF 157KB]
Newsletter No 2 - August 2012 [PDF 326KB]
Newsletter No 3 - February 2013 [PDF 281KB]
Newsletter No 4 - September 2013 [PDF 127KB]
Newsletter No 5 - March 2014 [PDF 110KB]
Newsletter No 6 - April 2015 [PDF 108KB]
Newsletter No 7 - November 2015 [PDF 211KB]
[Please contact us at email@example.com if you require an alternative format of these newsletters.]
Who can be in the study?
Women who are pregnant, without significant medical issues, planning to breastfeed, who have diabetes and who are booked to have their babies at the Mercy Hospital for Women, the Royal Women's Hospital, Monash Medical Centre, Barwon Health, the Royal Women's at Sandringham, and Frankston Hospital may be eligible for this study.
Approximately 650 women will take part in this study.
Interested in participating?
Join the DAME trial
Who are the researchers?
Prof Della Forster, Maternity and Midwifery Research, The Royal Women's Hospital and JLC; Dr Susan Jacobs, The Royal Women's Hospital; A/Prof Lisa Amir, JLC and The Royal Women's Hospital; Prof Peter Davis, The Royal Women's Hospital; Prof Susan Walker, Mercy Hospital for Women and The University of Melbourne; Ms Kerri McEgan, Mercy Hospital for Women; Dr Gillian Opie, Mercy Hospital for Women; Prof Christine East, Monash Medical Centre; Dr Lisa Gold, Deakin Health Economics, Deakin University .
Ms Anita Moorhead, The Royal Women's Hospital and JLC; A/Prof Susan Donath, Clinical Epidemiology and Biostatistics Unit (CEBU); Ms Amanda Aylward, The Royal Women's Hospital; Ms Catharine McNamara, Mercy Hospital for Women; Ms Rachael Ford, The Royal Women's Hospital.
Forster DA, Moorhead A, Jacobs S, Amir LH, Walker S, McEgan K, Opie G, McNamara C, Ford R. Is not testing a major change in clinical practice an ethical dilemma? Midwifery [Invited Letter] 2011;27(6):e301-e2. View this letter online
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. View this article online
Forster DA, Jacobs S, 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. View this article online
Who is funding the study?
This is a four year project funded by the National Health and Medical Research Council of Australia (NHMRC). NHMRC Project Grant no. 1005345.
Privacy and access to information
Information collected is kept confidential and the data will be used only for the purposes of this study. We have research ethics approval to conduct the DAME trial.
Australian and New Zealand Clinical Trial Registry Trial number: ACTRN12611000217909
The DAME trial is being co-ordinated at the Royal Women's Hospital, Mercy Hospital for Women, the Monash Medical Centre, Barwon Health, the Royal Women's at Sandringham, and Frankston Hospital by Anita Moorhead.