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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
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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
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Secondary ID [1]
284160
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Nil.
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Universal Trial Number (UTN)
U1111-1153-8160
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Trial acronym
MBM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stillbirth / fetal death
291253
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Condition category
Condition code
Reproductive Health and Childbirth
291598
291598
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
288858
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Prevention
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Intervention code [2]
288943
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Early detection / Screening
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Stillbirth at 28 weeks' gestation or more (among all women in the trial)
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Assessment method [1]
291542
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Timepoint [1]
291542
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At time of birth
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Secondary outcome [1]
307017
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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.
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Assessment method [1]
307017
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Timepoint [1]
307017
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From birth up to 28 days postpartum
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Secondary outcome [2]
307018
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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.
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Assessment method [2]
307018
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Timepoint [2]
307018
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At the commencement of the control period and at the end of the intervention period, for each study cluster.
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Secondary outcome [3]
307019
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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.
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Assessment method [3]
307019
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Timepoint [3]
307019
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At the end of pregnancy (or birth) and at 6 months postpartum
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Secondary outcome [4]
307020
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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.
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Assessment method [4]
307020
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Timepoint [4]
307020
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At the end of pregnancy (or birth) and at 6 months postpartum
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Secondary outcome [5]
307284
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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.
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Assessment method [5]
307284
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Timepoint [5]
307284
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Before and after the intervention periods
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Secondary outcome [6]
307285
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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).
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Assessment method [6]
307285
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Timepoint [6]
307285
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From entry into the trial through to 6 months postpartum
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Pregnant women with a lethal fetal congenital abnormality at 24-28 weeks' gestation.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Cluster randomisation in stepped-wedge design so that, by the end of the trial, all clusters have received the intervention.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/11/2016
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Actual
28/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300000
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Accrual to date
180000
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA
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Recruitment hospital [1]
9049
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Gold Coast University Hospital - Southport
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Recruitment hospital [2]
9050
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Logan Hospital - Meadowbrook
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Recruitment hospital [3]
9051
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Ipswich Hospital - Ipswich
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Recruitment hospital [4]
9052
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Nepean Hospital - Kingswood
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Recruitment hospital [5]
9053
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Liverpool Hospital - Liverpool
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Recruitment hospital [6]
9054
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The Canberra Hospital - Garran
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Recruitment hospital [7]
9055
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [8]
9056
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Dandenong Hospital - Dandenong
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Recruitment hospital [9]
9057
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Casey Hospital - Berwick
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Recruitment hospital [10]
9058
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Sunshine Hospital - St Albans
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Recruitment hospital [11]
12080
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [12]
12081
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Royal Hospital for Women - Randwick
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Recruitment hospital [13]
12082
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [14]
12083
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Mater Mother's Hospital - South Brisbane
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Recruitment hospital [15]
12084
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [16]
12085
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The Royal Women's Hospital - Parkville
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Recruitment hospital [17]
12086
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Mercy Hospital for Women - Heidelberg
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Recruitment hospital [18]
12087
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The Northern Hospital - Epping
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Recruitment postcode(s) [1]
24243
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2031 - Randwick
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Recruitment postcode(s) [2]
24242
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2050 - Camperdown
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Recruitment postcode(s) [3]
24244
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2065 - St Leonards
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Recruitment postcode(s) [4]
17547
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2170 - Liverpool
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Recruitment postcode(s) [5]
17548
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2605 - Garran
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Recruitment postcode(s) [6]
17546
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2747 - Kingswood
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Recruitment postcode(s) [7]
17552
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3021 - St Albans
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Recruitment postcode(s) [8]
24247
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3052 - Parkville
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Recruitment postcode(s) [9]
24249
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3076 - Epping
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Recruitment postcode(s) [10]
24248
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3084 - Heidelberg
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Recruitment postcode(s) [11]
17549
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3168 - Clayton
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Recruitment postcode(s) [12]
17550
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3175 - Dandenong
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Recruitment postcode(s) [13]
17551
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3806 - Berwick
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Recruitment postcode(s) [14]
24246
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4029 - Herston
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Recruitment postcode(s) [15]
24245
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4101 - South Brisbane
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Recruitment postcode(s) [16]
17544
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4131 - Meadowbrook
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Recruitment postcode(s) [17]
17543
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4215 - Southport
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Recruitment postcode(s) [18]
17545
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4305 - Ipswich
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Recruitment outside Australia
Country [1]
5851
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New Zealand
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State/province [1]
5851
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Funding & Sponsors
Funding source category [1]
288787
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Government body
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Name [1]
288787
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National Health and Medical Research Council
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Address [1]
288787
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
288787
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Australia
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Funding source category [2]
288788
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Charities/Societies/Foundations
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Name [2]
288788
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The Stillbirth Foundation of Australia
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Address [2]
288788
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Suite 101
114a Pyrmont Bridge Road
Annandale NSW 2038
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Country [2]
288788
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Australia
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Primary sponsor type
Individual
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Name
Associate Professor Vicki Flenady
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Address
Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
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Country
Australia
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Secondary sponsor category [1]
287486
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None
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Name [1]
287486
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Address [1]
287486
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Country [1]
287486
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290629
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Mater Health Services HREC
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Ethics committee address [1]
290629
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Level 2 Aubigny Place Mater Health Services South Brisbane QLD 4101
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Ethics committee country [1]
290629
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Australia
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Date submitted for ethics approval [1]
290629
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26/05/2014
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Approval date [1]
290629
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03/11/2015
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Ethics approval number [1]
290629
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Summary
Brief summary
Stillbirth directly affects over 2,700 families in Australia and New Zealand each year and is associated with devastating and long-lasting psychosocial impact. Some late-pregnancy stillbirths may be preventable with early detection of a baby's ill-health, which may be indicated by Decreased Fetal Movements (DFM). Maternal reporting of (DFM) has therefore been proposed as a simple, inexpensive stillbirth screening tool. This trial will evaluate ‘My Baby’s Movements’ (MBM): a package of interventions to raise awareness and promote early reporting and optimal clinical management of DFM. MBM will be evaluated as part of a large multi-centre clinical trial across participating hospitals in Australia and New Zealand. Over three years, women attending for antenatal care with a singleton pregnancy will be included in measurement of stillbirth rates and other birth outcomes using routinely collected data. Maternal psychosocial outcomes, health service use, acceptability of MBM, and cost will also be assessed.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
46526
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A/Prof Vicki Flenady
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Address
46526
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Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
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Country
46526
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Australia
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Phone
46526
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+617 316 31592
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Fax
46526
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Email
46526
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vicki.flenady@mater.uq.edu.au
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Contact person for public queries
Name
46527
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Ms Megan Weller
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Address
46527
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Mater Research Institute - The University of Queensland Level 3 Aubigny Place Mater Health Services South Brisbane QLD 4101
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Country
46527
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Australia
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Phone
46527
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+61 7 3163 7667
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Fax
46527
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Email
46527
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megan.weller@mater.uq.edu.au
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Contact person for scientific queries
Name
46528
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Vicki Flenady
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Address
46528
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Mater Research Institute - The University of Queensland
Level 2 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
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Country
46528
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Australia
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Phone
46528
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+617 316 31592
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Fax
46528
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Email
46528
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vicki.flenady@mater.uq.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Questions relating to data sharing can be directed to the below email address
mbmtrial@mater.uq.edu.au
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4570
Statistical analysis plan
Flenady, 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
mbmtrial@mater.uq.edu.au
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
Source
Title
Year of Publication
DOI
Embase
Encouraging awareness of fetal movements is harmful.
2018
https://dx.doi.org/10.1016/S0140-6736%2818%2931720-3
Embase
My Baby's Movements: A stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.
2019
https://dx.doi.org/10.1186/s12884-019-2575-1
N.B. These documents automatically identified may not have been verified by the study sponsor.
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