Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000748112
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
20/05/2019
Date last updated
10/11/2022
Date data sharing statement initially provided
20/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using antenatal expressing of colostrum to help new mothers breastfeed
Scientific title
The Antenatal Colostrum Expressing (ACE) Study: Effects on breastfeeding and effectiveness of video instruction vs face to face instruction.
Secondary ID [1] 298033 0
Nil
Universal Trial Number (UTN)
U1111-1232-1397
Trial acronym
Antenatal Colostrum Expressing (ACE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 312492 0
Breastfeeding 312493 0
Condition category
Condition code
Reproductive Health and Childbirth 311038 311038 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention groups and one control group for this study.

The Video (VI) intervention group will receive a link to an online instructional video on antenatal colostrum expression (ACE), along with instruction to hand express 2-3 times daily from 37 weeks gestation via written information and phone call. They will be asked to keep an expressing diary and will be contacted weekly via phone call for compliance checks. Participants will have access to the video online to view at home as often as they like.
The instructional video runs for 16 mins and includes a lactation consultant giving information on ACE and how to safely collect and store colostrum with demonstrations by pregnant women.

The Midwife (MW) intervention group will receive personal one-on-one instruction on ACE (approx. 15 mins) from a qualified midwife, along with instruction to hand express 2-3 times daily from 37 weeks gestation via written information and phone call. The MW group will also be asked to keep an expressing diary and will be contacted weekly via phone call until the birth for compliance checks.

Participants are advised to take their stored colostrum to hospital for use after birth if required.

As an optional part of the study, participants will have the opportunity to provide a postnatal colostrum sample for analysis.
Intervention code [1] 314265 0
Behaviour
Comparator / control treatment
For the control group, women will receive usual antenatal care. Once enrolled they will not have further contact with research staff until follow up data phone calls.
Usual antenatal care is defined as the standard care provided by the hospital’s antenatal service for the purposes of this study.
Control group
Active

Outcomes
Primary outcome [1] 319834 0
Infant feeding method (exclusive breastfeeding at 16 weeks post birth), assessed via telephone administered questionnaires. The questionnaires used in this trial were specifically designed for this study. The mothers’ antenatal questionnaire (MAQ) includes the validated Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF) questionnaire and the validated IOWA Infant Feeding Attitude Scale (IIFAS) questionnaire. Exclusive breastfeeding at the 1–4-month post birth questionnaires is self-reported by participants, using the World Health Organisation’s definition of exclusive breastfeeding where the infant receives only breastmilk, no other solids, or liquids except for drops or syrups consisting of vitamins, minerals, supplements, or medicines.
Timepoint [1] 319834 0
16 weeks post birth
Primary outcome [2] 319835 0
Breastfeeding confidence, assessed by the Breastfeeding Self Efficacy Scale.
Timepoint [2] 319835 0
4 weeks post birth
Secondary outcome [1] 369637 0
Special care nursery (SCN) admission and days in SCN - from medical record
Timepoint [1] 369637 0
Birth hospital stay
Secondary outcome [2] 369638 0
Infant feeding method (exclusive breastfeeding), assessed via telephone administered questionnaire (or via hospital record for the post birth time point). The questionnaires used in this trial were specifically designed for this study. The mothers’ antenatal questionnaire (MAQ) includes the validated Breastfeeding Self-Efficacy Scale-Short Form (BFSES-SF) questionnaire and the validated IOWA Infant Feeding Attitude Scale (IIFAS) questionnaire. Exclusive breastfeeding at the 1–4-month post birth questionnaires is self-reported by participants, using the World Health Organisation’s definition of exclusive breastfeeding where the infant receives only breastmilk, no other solids, or liquids except for drops or syrups consisting of vitamins, minerals, supplements, or medicines.
Timepoint [2] 369638 0
Secondary time points are:
In hospital post birth, plus one, four, eight, 12 weeks post birth
Secondary outcome [3] 369640 0
VI participants will be asked to provide feedback on the instructional materials provided and their experiences of being in the trial, via transcription and thematic analysis of a semi-structured telephone interview.
Timepoint [3] 369640 0
16 weeks (post birth)
Secondary outcome [4] 370374 0
First feed type - from medical record
Timepoint [4] 370374 0
At birth
Secondary outcome [5] 370375 0
Any formula administered in hospital, and type if relevant- from medical record
Timepoint [5] 370375 0
At birth hospital stay
Secondary outcome [6] 370377 0
Lactation consultant required in hospital or referral given for outpatient consult- from medical record
Timepoint [6] 370377 0
Discharge from birth hospital visit
Secondary outcome [7] 370593 0
Time to first feed - from medical record
Timepoint [7] 370593 0
At birth
Secondary outcome [8] 407509 0
Differences in post-birth colostrum nutritional content (including lactose, fat, protein) between those mothers who did and those who did not perform ACE.(optional outcome assessed in participants who opted-in only)
Timepoint [8] 407509 0
within 24 hours post birth
Secondary outcome [9] 407510 0
Differences in post-birth colostrum composition for growth factors (including epidermal growth factor (EGF) and transforming growth factor (TGF)) between those mothers who did and those who did not perform ACE (optional outcome assessed in participants who opted-in only).
Timepoint [9] 407510 0
within 24 hours post birth
Secondary outcome [10] 407511 0
Differences in post-birth colostrum composition of molecules influencing microbiota and infant immune defense (including lactoferrin, IgA, sCD14), between those mothers who did and those who did not perform ACE (optional outcome assessed in participants who opted-in only).
Timepoint [10] 407511 0
within 24 hours post birth
Secondary outcome [11] 407512 0
Differences in post-birth colostrum bioactive immune factor content (including interleukins, tumour necrosis factor-a, thymic stromal lymphopoietin, interferon-gamma) between those mothers who did and those who did not perform ACE (optional outcome assessed in participants who opted-in only).
Timepoint [11] 407512 0
within 24 hours post birth

Eligibility
Key inclusion criteria
Nulliparous women, singleton pregnancy, planning to breastfeed, and able to speak, read and write in English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Relevant maternal or infant medical conditions including history of threatened/actual premature labour, cervical incompetence, cervical suture in situ, antepartum haemorrhage, placenta praevia and suspected fetal compromise, fetal anomaly, infant born <37 weeks. Diagnosis of gestational Diabetes Mellitus is an exclusion criteria for analysis between control and intervention groups.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done as the person determining if a subject was eligible for inclusion in the trial will be unaware, when this decision was made, to which group the subject would be allocated. Allocation will done via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Balancing variables will be used, maternal age (<30, above or equal to 30 years), and SES (low, medium, high; determined by postcode, education level). The biased coin approach (P=0.7) will be used to determine group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The research will be conducted in two phases:
Phase 1) an observation period where data is collected for the Control group, and
Phase 2) a period of randomisation to either the VI or MW groups. The phased design provides the benefit of a quarantined period of observation and data collection from the Control group. Randomising to all three groups simultaneously would risk contamination (via artificially increasing knowledge above control levels) of the Control group, as pregnant women attending antenatal classes in the same hospital may discuss and share aspects of their care (data suggest no seasonal breastfeeding differences).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
10/09/2019
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
936
Accrual to date
298
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302562 0
Government body
Name [1] 302562 0
WA Department of Health
Country [1] 302562 0
Australia
Funding source category [2] 311025 0
Charities/Societies/Foundations
Name [2] 311025 0
Stan Perron Charitable Foundation
Country [2] 311025 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 302470 0
None
Name [1] 302470 0
Address [1] 302470 0
Country [1] 302470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303207 0
Women and Newborn Health Service Ethics Committee
Ethics committee address [1] 303207 0
Ethics committee country [1] 303207 0
Australia
Date submitted for ethics approval [1] 303207 0
22/01/2019
Approval date [1] 303207 0
13/05/2019
Ethics approval number [1] 303207 0
ethics approval RGS0000001504
Ethics committee name [2] 304542 0
Ramsay Health Care (RHC) WA|SA HREC (previously known as Human Research Ethics Committee of Joondalup Health Campus)
Ethics committee address [2] 304542 0
Ethics committee country [2] 304542 0
Australia
Date submitted for ethics approval [2] 304542 0
Approval date [2] 304542 0
22/04/2019
Ethics approval number [2] 304542 0
ethics approval REF1901

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92850 0
A/Prof Therese O'Sullivan
Address 92850 0
Building 21, School of Medical and Health Science,
Edith Cowan University,
Joondalup Dr
Joondalup WA 6027
Country 92850 0
Australia
Phone 92850 0
+61 0863043529
Fax 92850 0
Email 92850 0
[email protected]
Contact person for public queries
Name 92851 0
Therese O'Sullivan
Address 92851 0
Building 21, School of Medical and Health Science,
Edith Cowan University,
Joondalup Dr
Joondalup WA 6027
Country 92851 0
Australia
Phone 92851 0
+61 0863043529
Fax 92851 0
Email 92851 0
[email protected]
Contact person for scientific queries
Name 92852 0
Therese O'Sullivan
Address 92852 0
Building 21, School of Medical and Health Science,
Edith Cowan University,
Joondalup Dr
Joondalup WA 6027
Country 92852 0
Australia
Phone 92852 0
+61 0863043529
Fax 92852 0
Email 92852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data after publication
When will data be available (start and end dates)?
From immediately after publication up till approximately 2024.
Available to whom?
Researchers who provide a methodologically sound proposal, at the discretion of the research team
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Via secure electronic transfer subject to approvals by Principal Investigator and data access agreement


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
No additional documents have been identified.