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

Investigation of the effect of antenatal milk expressing on babies of women with diabetes in pregnancy compared to the outcomes of babies of women with diabetes in pregnancy receiving standard care

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000217909
Acronym
DAME
Enrollment
635
Registered
2011-02-28
Start date
2011-07-06
Completion date
2015-10-23
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Infants of women with diabetes in pregnancy have an increased risk of low blood sugar and other complications after birth and of developing diabetes and being obese later in life. Many maternity providers encourage these women to express breast milk before birth to have it available if the infant needs supplementary feeding. Evidence for this practice is lacking so we are planning the first study exploring the safety and effectiveness of antenatal expression of breast milk in late pregnancy for women with diabetes in pregnancy.

Interventions

Women with diabetes in pregnancy who are intending to breastfeed will commence twice daily antenatal milk expressing from 36 weeks gestation until birth.

Sponsors

Judith Lumley Centre, La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Any woman with pre-existing or gestational diabetes; between 34 and 36 weeks gestation; with a singleton pregnancy in a cephalic presentation; attending the study sites for pregnancy care as a public patient; planning to breastfeed and able to speak , read and write in English

Exclusion criteria

Women -any history of antepartum haemorrhage, or placenta praevia -an unknown or classical caesarean section scar or more than one lower uterine segment caesarean section scar -any suspicion of fetal compromise - a known fetal abnormality.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026