Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000217909
Ethics application status
Approved
Date submitted
23/02/2011
Date registered
28/02/2011
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes and antenatal milk expressing (DAME) : a randomised controlled trial.
Scientific title
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
Secondary ID [1] 259624 0
NIL
Universal Trial Number (UTN)
U1111-1119-4839
Trial acronym
DAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal admission to Special and Intensive care, , 261183 0
Neonatal/infant feeding 261184 0
Hypoglycaemia 261185 0
Lactation 261246 0
Pregnancy outcomes 261247 0
Maternal diabetes, 261248 0
Condition category
Condition code
Reproductive Health and Childbirth 259337 259337 0 0
Complications of newborn
Reproductive Health and Childbirth 259338 259338 0 0
Childbirth and postnatal care
Metabolic and Endocrine 259390 259390 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with diabetes in pregnancy who are intending to breastfeed will commence twice daily antenatal milk expressing from 36 weeks gestation until birth.
Intervention code [1] 258057 0
Treatment: Other
Intervention code [2] 258104 0
Prevention
Comparator / control treatment
Women with diabetes in pregnancy who are intending to breastfeed will receive usual care. In usual care women are not advised to commence expressing breast milk antenatally.
Control group
Active

Outcomes
Primary outcome [1] 262201 0
To establish whether the practice of antenatal breast milk expressing from 36 weeks gestation for women with diabetes in pregnancy increases the proportion of infants who require admission to the special or intensive care nursery compared with infants of women with diabetes in pregnancy receiving standard care (30% vs 20%).
Timepoint [1] 262201 0
Admission during the hospital stay following birth - data from medical record
Secondary outcome [1] 273226 0
To establish whether the practice of antenatal breast milk expressing from 36 weeks gestation for women with diabetes in pregnancy increases the proportion of of infants receiving exclusive breast milk at three months of age compared with infants of women with diabetes in pregnancy receiving standard care (52% vs 40%).
Timepoint [1] 273226 0
Three months postpartum by telephone interview
Secondary outcome [2] 273333 0
To establish whether the practice of antenatal breast milk expressing from 36 weeks gestation for women with diabetes in pregnancy increases the proportion of of infants receiving exclusive breast milk during the hospital stay after birth compared with infants of women with diabetes in pregnancy receiving standard care (37% vs 25%).
Timepoint [2] 273333 0
Admission during the hospital stay following birth - data from medical record
Secondary outcome [3] 273334 0
To establish whether the practice of antenatal breast milk expressing from 36 weeks gestation for women with diabetes in pregnancy decreases the mean gestation at birth compared with infants of women with diabetes in pregnancy receiving standard care (37 weeks vs 38 weeks).
Timepoint [3] 273334 0
Collected from the medical record following birth

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computerised random number generator will be accessed by computer to ascertain the woman's allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permutated blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Data abstarction for the primary outcome will be blinded to group allocation. Medical records which will be seen by care providers will note study participation but not trial arm. Women (participants) can not be blinded to allocation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2011
Actual
6/07/2011
Date of last participant enrolment
Anticipated
Actual
23/10/2015
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
658
Accrual to date
Final
635
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2168 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 2169 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [3] 2170 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 2171 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [5] 4597 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 7849 0
3084 - Heidelberg
Recruitment postcode(s) [2] 7850 0
3168 - Clayton
Recruitment postcode(s) [3] 7851 0
3220 - Geelong
Recruitment postcode(s) [4] 7852 0
3052 - Parkville
Recruitment postcode(s) [5] 12201 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 258554 0
Government body
Name [1] 258554 0
National Health and Medical Research Council, Australia
Country [1] 258554 0
Australia
Primary sponsor type
University
Name
Judith Lumley Centre, La Trobe University
Address
Level 3, George Singer Building, La Trobe University, Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 257691 0
Hospital
Name [1] 257691 0
Royal Women's Hospital
Address [1] 257691 0
Locked bag 300,
Parkville,
Victoria. 3052
Country [1] 257691 0
Australia
Secondary sponsor category [2] 257692 0
Hospital
Name [2] 257692 0
Mercy Hospital for Women
Address [2] 257692 0
163 Studley Rd
Heidelberg,
Victoria. 3084
Country [2] 257692 0
Australia
Secondary sponsor category [3] 284831 0
Hospital
Name [3] 284831 0
Monash Medical Centre, Southern Health
Address [3] 284831 0
246 Clayton Road
Clayton VIC 3168
Country [3] 284831 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260524 0
Mercy Hospital For Women
Ethics committee address [1] 260524 0
163 Studley Rd
Heidelberg,
Victoria. 3084
Ethics committee country [1] 260524 0
Australia
Date submitted for ethics approval [1] 260524 0
19/01/2011
Approval date [1] 260524 0
08/03/2011
Ethics approval number [1] 260524 0
MHW HREC ID number 11/06
Ethics committee name [2] 260525 0
Royal Womens Hospital
Ethics committee address [2] 260525 0
Locked bag 300,
Parkville,
Victoria. 3052
Ethics committee country [2] 260525 0
Australia
Date submitted for ethics approval [2] 260525 0
17/01/2011
Approval date [2] 260525 0
23/03/2011
Ethics approval number [2] 260525 0
RWH HREC ID number 11/07
Ethics committee name [3] 260544 0
La Trobe University Human Ethics Committee
Ethics committee address [3] 260544 0
La Trobe University
Bundoora
Victoria. 3086
Ethics committee country [3] 260544 0
Australia
Date submitted for ethics approval [3] 260544 0
19/01/2011
Approval date [3] 260544 0
31/03/2011
Ethics approval number [3] 260544 0
La Trobe University Human Ethics Application No. 11-004
Ethics committee name [4] 288063 0
Southern Health HREC
Ethics committee address [4] 288063 0
246 Clayton Road
Clayton VIC 3168
.
Ethics committee country [4] 288063 0
Australia
Date submitted for ethics approval [4] 288063 0
05/06/2012
Approval date [4] 288063 0
13/07/2012
Ethics approval number [4] 288063 0
MMC 12181-B
Ethics committee name [5] 290665 0
Barwon Health
Ethics committee address [5] 290665 0
Corporate Office
Ryrie St
Geelong
Victoria 3220
Ethics committee country [5] 290665 0
Australia
Date submitted for ethics approval [5] 290665 0
Approval date [5] 290665 0
26/03/2013
Ethics approval number [5] 290665 0
BH 13/06
Ethics committee name [6] 293827 0
Peninsula Health Human Resaerch Ethics Committee
Ethics committee address [6] 293827 0
PO Box 192 Mount Eliza, Victoria. 3930
Ethics committee country [6] 293827 0
Australia
Date submitted for ethics approval [6] 293827 0
Approval date [6] 293827 0
10/07/2014
Ethics approval number [6] 293827 0
HREC/14/PH/21

Summary
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.
Trial website
Trial related presentations / publications
Forster DA, Jacobs S, Amir LH, et al. Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised
controlled trial. BMJ Open 2014;4:e006571.
doi:10.1136/bmjopen-2014-006571

Forster DA, Moorhead AM, Jacobs SE, ... Amir LH. Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial.
The Lancet. 2017 Jun 3;389(10085):2204-2213. doi: 10.1016/S0140-6736(17)31373-9
Public notes

Contacts
Principal investigator
Name 32228 0
Prof Della Forster
Address 32228 0
Judith Lumley Centre, La Trobe University, Level 3 George Singer Building, Bundoora, Victoria. 3086
Country 32228 0
Australia
Phone 32228 0
+61 3 9479 8783
Fax 32228 0
Email 32228 0
[email protected]
Contact person for public queries
Name 15475 0
Ms Anita Moorhead
Address 15475 0
Judith Lumley Centre, La Trobe University, Level 3 George Singer Building, Bundoora, Victoria. 3086
Country 15475 0
Australia
Phone 15475 0
+ 61 3 8345 2932
Fax 15475 0
Email 15475 0
[email protected]
Contact person for scientific queries
Name 6403 0
Prof Professor Della Forster
Address 6403 0
Judith Lumley Centre, La Trobe University, Level 3 George Singer Building, Bundoora, Victoria. 3086
Country 6403 0
Australia
Phone 6403 0
+61 39479 8783
Fax 6403 0
Email 6403 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdvising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial.2017https://dx.doi.org/10.1016/S0140-6736%2817%2931373-9
N.B. These documents automatically identified may not have been verified by the study sponsor.