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Trial registered on ANZCTR


Registration number
ACTRN12614000291684
Ethics application status
Approved
Date submitted
25/02/2014
Date registered
19/03/2014
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
My Baby’s Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy
Scientific title
My Baby’s Movements: A mobile phone software program about maternal fetal movement awareness, designed for women with a singleton pregnancy to prevent stillbirth at 28 weeks' gestation or more
Secondary ID [1] 284160 0
Nil.
Universal Trial Number (UTN)
U1111-1153-8160
Trial acronym
MBM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stillbirth / fetal death 291253 0
Condition category
Condition code
Reproductive Health and Childbirth 291598 291598 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
My Baby's Movements (MBM): a package of interventions to raise awareness and promote early reporting and best-practice management of Decreased Fetal Movements (DFM) in the third-trimester of pregnancy, including a mobile phone application for pregnant women and e-learning program for clinicians.

MBM will be a personalised, user-controlled mobile phone software program that will provide information about fetal movement and when and how to report DFM. At a time and frequency determined by the woman, MBM will also send reminders to prompt awareness of fetal movements. Eligible women will be given a unique code to access MBM and become a registered user via their existing mobile phone. Women will be invited to use MBM from 28 weeks gestation to birth. Data generated from use of MBM (frequency and type of use, or discontinuation) will be sent to a secure database accessible to the research team.

The e-learning program for clinicians will serve as education and training around the Australian and New Zealand clinical practice guidelines for the management of women who report DFM. The program will be computer-based and will seek to improve care around DFM. The program will take each clinician approximately 20 minutes to complete (one-sitting only), and can be used in ongoing hospital in-service education.
Intervention code [1] 288858 0
Prevention
Intervention code [2] 288943 0
Early detection / Screening
Comparator / control treatment
Standard care. Some hospitals routinely provide verbal and/or written information about fetal movements during standard antenatal care, but this is not in the form of an interactive, mobile phone program (MBM). Care during the intervention period will differ to standard care in that in MBM will offer a ready source of more detailed information about fetal movements and what to expect, as well as prompts about fetal movement awareness, and a timer to facilitate close movement monitoring for women who are concerned about their baby's movements. NB: Pilot-testing of MBM will determine the utility of these features and therefore changes and refinements may be made prior to final product being rolled-out in the clinical trial.
Control group
Active

Outcomes
Primary outcome [1] 291542 0
Stillbirth at 28 weeks' gestation or more (among all women in the trial)
Timepoint [1] 291542 0
At time of birth
Secondary outcome [1] 307017 0
Adverse neonatal outcome - subset of 4377 babies only: Composite measure of birth outcomes including Apgar Score <7 at 5 minutes; umbilical artery pH <7.0; intubation and ventilation at birth; hypoxic ischemic encephalopathy; neonatal seizures; Meconium Aspiration Syndrome; neonatal intensive care greater than 5 days; use of mechanical ventilation; neonatal death.
Timepoint [1] 307017 0
From birth up to 28 days postpartum
Secondary outcome [2] 307018 0
Health service utilisation - subset of 4377 women only: Assessed via audits of presentations for decreased fetal movements including the duration of decreased movement at presentation and details and outcome of any clinical assessments.
Timepoint [2] 307018 0
At the commencement of the control period and at the end of the intervention period, for each study cluster.
Secondary outcome [3] 307019 0
Woman’s psychosocial outcomes and health-seeking behaviour - subset of 4377 women only: The Prenatal Attachment Inventory (PAI); Cambridge Worry Scale; the State-Trait Anxiety Index; Edinburgh Postnatal Depression Scale (EPDS); Perinatal Grief Scale; quality of life (QoL)(AQol8D); Health status (SF36); and maternal reporting of decreased fetal movements delayed by >24 hours.
Timepoint [3] 307019 0
At the end of pregnancy (or birth) and at 6 months postpartum
Secondary outcome [4] 307020 0
Women's knowledge of fetal movements and acceptability of MBM - subset of 4377 women only: Surveys specifically designed for this study, using a combination of Likert and rating scales, multiple choice, and open-ended questions.
Timepoint [4] 307020 0
At the end of pregnancy (or birth) and at 6 months postpartum
Secondary outcome [5] 307284 0
Clinicians' knowledge of fetal movements and acceptability of MBM: Surveys specifically designed for this study, using a combination of Likert and rating scales, multiple choice, and open-ended questions.
Timepoint [5] 307284 0
Before and after the intervention periods
Secondary outcome [6] 307285 0
Economic impact - subset of 4377 women plus all women who had a stillbirth: Medicare data on health care costs incurred through reimbursement for pharmaceutical benefits schedule (PBS) and medical benefits schedule (MBS).
Timepoint [6] 307285 0
From entry into the trial through to 6 months postpartum

Eligibility
Key inclusion criteria
Women with a singleton pregnancy attending for antenatal care at participating sites, and clinicians providing antenatal care at participating sites. Women at any stage of pregnancy are eligible for entry into the trial.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women with a lethal fetal congenital abnormality at 24-28 weeks' gestation.

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)
This trial will use a stepped-wedge cluster randomisation schedule whereby hospital groups (clusters) rather than individuals will be randomised. Allocation will be concealed up until 8 weeks prior to the implementation of the intervention in each cluster. The allocation schedule will be held at the central coordinating centre, and the holder of the allocation schedule will contact hospitals to notify of allocation at the 8-week-prior-to-implementation timepoint.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial will use a stepped-wedge cluster randomisation schedule whereby hospital groups (clusters) rather than individuals will be randomised. Clusters will be randomised to timing of intervention implementation, using a computer generated random number table developed off-site by a Biostatistician who is not involved in clinical care.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster randomisation in stepped-wedge design so that, by the end of the trial, all clusters have received the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Reduction in stillbirth: The study will include at least 27 hospitals in ANZ with an average of 3,170 singleton births per year (range: 1400, 7000) giving 256,700 total births over 3 years. The current stillbirth rate >28weeks is 3 per 1000. We therefore would expect (without the MBM package to raise maternal awareness and early reporting of DFM) 770 stillbirths (>28weeks), with 10% due to major congenital abnormalities where the intervention is unlikely to have an effect, leaving 693 stillbirths. MBM is hypothesised to reduce the rate to 2 per 1000, which considered an achievable benchmark for a high income country and was the effect size observed in the Norwegian study. We calculated statistical power using the methodology for stepped wedge designs proposed in Hussey and Hughes (2007). The calculation, based on equations (#7) and (#8) assumes: significance level of 5%; analysis by generalised linear mixed model; births equally distributed across hospital groupings; baseline stillbirth rate 0.3%; intervention stillbirth rate: 0.2%; intra-class correlation (ICC)=0.005. The ICC was obtained from the Queensland Perinatal Data Collection and reflects the fact that for large clusters (n=3170), the ICC is small. The statistical power depends on the total number of women birthing and also the number of groups in which the intervention is implemented at each stage of the stepped wedge design and the duration of recruitment at each “step”. We propose sequential introduction of the intervention into 8 groups of 3-4 hospitals at four month intervals; over a total of three years. This will give 89% power to detect a 30% relative risk reduction in stillbirth rates (from 3/1000 to 2/1000), 85% power to detect a 25% reduction, and 80% power to for a 15% reduction. The trial methods have been harmonised with that of a trial in Scotland (led by Jane Norman) (330,000 births over 3 years). Combining data from the two trials (786,700 births), would give 89% power to detect a 10% decrease in stillbirth rates.


The initial analysis will examine baseline characteristics of all women in the two time periods, as an indication of comparable groups. Data analysis to determine the overall effectiveness of the intervention will involve comparison of the data points in the control section of the wedge with those in the intervention section, adjusting for potential confounders. For the binary outcomes, data will be analysed by generalised linear mixed model with a random effect for hospital group and fixed effects for the intervention implementation and study time period. Outcomes measured on a continuous scale will be analysed in a normal linear mixed model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/11/2016
Actual
28/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300000
Accrual to date
180000
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA
Recruitment hospital [1] 9049 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 9050 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 9051 0
Ipswich Hospital - Ipswich
Recruitment hospital [4] 9052 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 9053 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 9054 0
The Canberra Hospital - Garran
Recruitment hospital [7] 9055 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 9056 0
Dandenong Hospital - Dandenong
Recruitment hospital [9] 9057 0
Casey Hospital - Berwick
Recruitment hospital [10] 9058 0
Sunshine Hospital - St Albans
Recruitment hospital [11] 12080 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [12] 12081 0
Royal Hospital for Women - Randwick
Recruitment hospital [13] 12082 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [14] 12083 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [15] 12084 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [16] 12085 0
The Royal Women's Hospital - Parkville
Recruitment hospital [17] 12086 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [18] 12087 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 17543 0
4215 - Southport
Recruitment postcode(s) [2] 17544 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 17545 0
4305 - Ipswich
Recruitment postcode(s) [4] 17546 0
2747 - Kingswood
Recruitment postcode(s) [5] 17547 0
2170 - Liverpool
Recruitment postcode(s) [6] 17548 0
2605 - Garran
Recruitment postcode(s) [7] 17549 0
3168 - Clayton
Recruitment postcode(s) [8] 17550 0
3175 - Dandenong
Recruitment postcode(s) [9] 17551 0
3806 - Berwick
Recruitment postcode(s) [10] 17552 0
3021 - St Albans
Recruitment postcode(s) [11] 24242 0
2050 - Camperdown
Recruitment postcode(s) [12] 24243 0
2031 - Randwick
Recruitment postcode(s) [13] 24244 0
2065 - St Leonards
Recruitment postcode(s) [14] 24245 0
4101 - South Brisbane
Recruitment postcode(s) [15] 24246 0
4029 - Herston
Recruitment postcode(s) [16] 24247 0
3052 - Parkville
Recruitment postcode(s) [17] 24248 0
3084 - Heidelberg
Recruitment postcode(s) [18] 24249 0
3076 - Epping
Recruitment outside Australia
Country [1] 5851 0
New Zealand
State/province [1] 5851 0

Funding & Sponsors
Funding source category [1] 288787 0
Government body
Name [1] 288787 0
National Health and Medical Research Council
Country [1] 288787 0
Australia
Funding source category [2] 288788 0
Charities/Societies/Foundations
Name [2] 288788 0
The Stillbirth Foundation of Australia
Country [2] 288788 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Vicki Flenady
Address
Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 287486 0
None
Name [1] 287486 0
Address [1] 287486 0
Country [1] 287486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290629 0
Mater Health Services HREC
Ethics committee address [1] 290629 0
Ethics committee country [1] 290629 0
Australia
Date submitted for ethics approval [1] 290629 0
26/05/2014
Approval date [1] 290629 0
03/11/2015
Ethics approval number [1] 290629 0

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

Contacts
Principal investigator
Name 46526 0
A/Prof Vicki Flenady
Address 46526 0
Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Country 46526 0
Australia
Phone 46526 0
+617 316 31592
Fax 46526 0
Email 46526 0
[email protected]
Contact person for public queries
Name 46527 0
Ms Megan Weller
Address 46527 0
Mater Research Institute - The University of Queensland Level 3 Aubigny Place Mater Health Services South Brisbane QLD 4101
Country 46527 0
Australia
Phone 46527 0
+61 7 3163 7667
Fax 46527 0
Email 46527 0
[email protected]
Contact person for scientific queries
Name 46528 0
Vicki Flenady
Address 46528 0
Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Country 46528 0
Australia
Phone 46528 0
+617 316 31592
Fax 46528 0
Email 46528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Questions relating to data sharing can be directed to the below email address
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4570Statistical analysis planFlenady, Vicki, Warrilow, Kara, Coory, Michael, Weller, Megan, Gardener, Glenn, Middleton, Philippa, … Crowther, Caroline. (2019, May 31). My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy: Statistical Analysis Plan (Version 1). Zenodo. http://doi.org/10.5281/zenodo.3237336[email protected] https://zenodo.org/record/3237336#.XXBdrC4zbmE



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEncouraging awareness of fetal movements is harmful.2018https://dx.doi.org/10.1016/S0140-6736%2818%2931720-3
EmbaseMy Baby's Movements: A stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.2019https://dx.doi.org/10.1186/s12884-019-2575-1
N.B. These documents automatically identified may not have been verified by the study sponsor.