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Report on the Results of the DAME Study

This report, by ALCI member Denise McGuinness IBCLC and Clinical Midwife Specialist (Lactation) at The National Maternity Hospital, Holles Street, is from the International Lactation Consultants Association Conference in Toronto, in July 2017. Denise was offered a small bursary by ALCI to attend this conference.

 

 

Presentation: The Diabetes and Antenatal Milk Expressing (DAME) Study. Anita Moorehead

The Diabetes and Antenatal Milk Expressing (DAME) study is a randomised controlled trial carried out by a team of researchers in Australia. The findings from this study were presented by Anita Moorhead (Registered Midwife) to the International Lactation Consultants Association (ILCA) Conference in Toronto, Canada in July 2017. The study was part of Anita Moorhead’s PhD.

 

The study is particularly interesting as type 2 diabetes and gestational diabetes are increasing globally. It is recognised that women with diabetes in pregnancy are at increased risk of not breastfeeding exclusively. This group of new born infants are at increased risk of hypoglycaemia and admission to a neonatal unit. Infant formula is more likely to be offered to these babies if there is no available colostrum. Babies are also at increased risk of separation from their mothers due to admission to the NICU. The study aim was to determine if antenatal expression of colostrum was a safe practice for women with diabetes in pregnancy.

 

The study was a multicentre, randomised control trial which involved six hospitals in Victoria, Australia. A total of 6565 women were assessed for eligibility, however, only 2593 women were subsequently eligible to participate in the study. Interestingly, 3972 women were excluded from the study, the majority due to obstetric risk (n= 1004).

 

Inclusion criteria were as follows: Pregnant women wishing to breastfeed with pre-existing or gestational diabetes, between 34 to 37 weeks gestation, single pregnancy and baby with a cephalic presentation.

 

Exclusion criteria included the following: any history of antepartum haemorrhage or placenta praevia, a previous classical caesarean scar or more than one lower segment caesarean section, any indication of compromise to the baby in utero, growth restriction, larger baby, polyhydramnios, foetal anomaly to include maternal obstetric or medical issues.

 

Method- Women with diabetes in pregnancy were randomised to either expressing colostrum twice per day for no more than 10 minutes, from 36 weeks gestation or standard care by the obstetric and diabetes team. A total of 777 women with diabetes were recruited with 635 women randomised to each group as follows: 319 women were allocated to the antenatal hand expression group and 317 women were allocated to standard obstetric and diabetic care. The majority of women had gestational diabetes, were expecting their first baby with half the women reported as obese or overweight.

Women included in the study were provided with written and verbal instruction in relation to the technique of hand expression, collection in a syringe, freezing and storage. The colostrum was labelled with the hospital medical identification label and transported frozen, where it was placed in a dedicated hospital freezer following arrival at the hospital for birth.

 

Outcomes

  1. The majority of women, 134 (42%) expressed >/= to 20 times, 80 (25%) women expressed 6-19 times and interestingly, 19 (6%) had not expressed following randomisation to the research study. It was recognised that early feeding volumes expressed were small. The average volume of colostrum expressed was 5.5 mls.
  2. The number of infants admitted to the neonatal intensive care unit did not differ between randomised groups. The three main reasons for admission to the NICU were as follows: hypoglycaemia, suspected infection and respiratory distress. In the antenatal expressing group the most serious adverse event for babies was respiratory distress (<1%) of 317 infants.
  3. The mean gestational age at birth was also comparable.
  4. There was an increase in exclusive breastfeeding in- hospital with this cohort of babies. This avoided formula milk among this group of babies during the early feeding stage, which the authors suggest may have long term implications for future development of diabetes in these infants.

 

The DAME study was the first randomised controlled trial to test the practice of antenatal hand expression of colostrum. The authors concluded that there was no harm in advising women with diabetes in pregnancy at low risk of complications to hand express colostrum from 36 weeks gestation. However, they issue a note of caution that the study results should not be extrapolated to high risk populations.

 

The following paper supported the accuracy of the information provided at the conference.

Forster, D.A., Moorehead, A.M., Jacobs, S.E., Davis, P.G., Walker, S.P., McEgan, K.M., Opie, G.F., Donath, S.M., Gold, L., McNamara, C., Aylward, A., East, C., Ford, R., Amir, L. (2017) Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing (DAME)): a multicentre, unblended, randomised controlled trial. The Lancet. 389, pp.2204-2213.