Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000167763
Ethics application status
Approved
Date submitted
13/01/2022
Date registered
1/02/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
1/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
MOHMQuit Trial - Midwives and Obstetricians Helping Mothers to Quit Smoking
Scientific title
The MOHMQuit trial – a stepped wedge cluster-randomised trial of the effect of Midwives and Obstetricians Helping Mothers to Quit smoking through the provision of evidence-based, best practice smoking cessation support
Secondary ID [1] 306196 0
Nil known
Universal Trial Number (UTN)
U1111-1273-1643
Trial acronym
MOHMQuit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 324901 0
Pregnancy 324902 0
Condition category
Condition code
Public Health 322335 322335 0 0
Health promotion/education
Public Health 322336 322336 0 0
Health service research
Public Health 322337 322337 0 0
Other public health
Reproductive Health and Childbirth 322338 322338 0 0
Normal pregnancy
Reproductive Health and Childbirth 322339 322339 0 0
Antenatal care
Mental Health 322459 322459 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MOHMQuit intervention

MOHMQuit (Midwives and Obstetricians Helping Mothers to Quit) is a multicomponent, system-based intervention to increase provision of smoking cessation support to pregnant women attending public antenatal services, using the 5As approach (Ask, Advise, Assess, Assist and Arrange follow-up). MOHMQuit specifically targets identified barriers to providing smoking cessation support (SCS), and includes elements for midwives, Aboriginal health workers (AHWs), obstetricians and maternity service leaders, as well as systems supports. Based on previous research (Passey et al., 2020; Longman et al., 2018) and designed collaboratively with input from multiple stakeholders across the NSW Health system, the MOHMQuit intervention is a systems-change intervention which was designed using a theoretically informed intervention development process – the Behaviour Change Wheel (Michie, Atkins, & West, 2014). MOHMQuit has been designed to be a sustainable systems-change intervention to address gaps in the provision of SCS by clinicians and ensure ongoing support for SCS from service leaders. Further details regarding the development and design of the MOHMQuit intervention are provided in two published papers (Passey et al., 2021; Longman et al., 2021).

The MOHMQuit intervention is provided over a three-month period, with ongoing support following this intervention period through the establishment of a community of practice. The intervention targets maternity service leaders (Midwifery Unit Managers, Clinical Midwifery Educators, Clinical Midwifery Consultants and the Obstetric Director) and clinicians (midwives, Aboriginal Health Workers, obstetricians and obstetric trainees) and has multiple components:

All participants will be requested to complete two short online training modules developed by the NSW Health Education and Training Institute (HETI), prior to other components. These modules take approximately 30 minutes each to complete and address: NSW Health policy regarding SCS; knowledge of harms of smoking in pregnancy; the evidence for SCS; use of the 5As; and use of NRT in pregnancy.

Clinical Midwifery Consultants (CMCs):
Initial engagement prior to the implementation phase to clarify their role in supporting practice change and the MOHMQuit intervention. At each site, a one-hour ‘warm up’ meeting will be held eight weeks before implementation, followed by a second ‘warm up’ meeting two weeks before implementation at the site. These meetings will be held virtually online and be facilitated by several members of the research team. The midwifery partner investigators at each site will attend these meetings, and invite maternity service leaders to attend, namely the Midwifery Unit Manager (MUM), Clinical Midwifery Consultant (CMC), lead obstetrician at each site. The first warm-up meeting will cover:
• Introduction to MOHMQuit
• Planning for the training, including inviting participants, logistics of rostering, and models for delivering training.
• Discussing how MOHMQuit training will work at their site, including training dates, follow-up support and mechanisms for capturing issues or problems to be addressed. COVID safety plan/any other safety issues

For maternity service leaders:
The maternity service leader component will be provided prior to the clinician components below, in order to maximise their support for the practice-change in their service. At each site, one 3-hour group workshop will be held with maternity service leaders (MUMs, CMCs, Clinical Midwifery Educators (CMEs) and obstetric leads). This workshop will cover: SCS leadership; reviewing eMaternity reports (eMaternity is the electronic medical record system used in maternity services and the reports provide local performance data on provision of SCS); action planning, including initial steps; developing care pathways for SCS; developing and maintaining champions; expectations regarding next steps and support for MOHMQuit within their service, including development of a plan with deadlines for actions.

Training for the leadership group will be provided by a senior CMC who is part of the research team, and who has extensive experience in leadership, evidence-based practice and training within NSW maternity services, and with detailed knowledge of all components of the MOHMQuit intervention.

Resources provided for their ongoing use will include: a template for generating eMaternity reports on provision of SCS in their clinic; guidance on use of the eMaternity reports for quality improvement; a clinic/service action planning tool; guidance on developing champions; and guidance on developing local care pathways.

For midwives and Aboriginal Health Workers:
Full-day workshop covering: the importance of providing SCS; how to provide effective SCS; how to use the MOHMQuit resources; using tools for self-monitoring provision of SCS and action planning; documentation of SCS in eMaternity.

Training will be provided jointly by a CMC, and an accredited smoking cessation trainer, with experience specifically related to smoking in pregnancy.

Resources provided for their ongoing use will include: 11 short videos demonstrating critical techniques in providing SCS; guidance on recording smoking information in eMaternity; information on NSW Quitline; summary guide of the 5As; Assist and arrange follow-up flip booklet; Helpful hints for clinicians; reference card to pin on badge holder; self-help booklet for use with women; NRT information sheets for clinicians; and NRT information for women. These evidence-based print and video resources were designed specifically for the MOHMQuit trial (Longman et al., 2021).

For obstetricians and obstetric trainees:
One hour workshop covering: the importance of providing SCS; how to provide effective SCS; how to use the MOHMQuit resources; documentation of SCS in eMaternity

Training will be provided jointly by a CMC, and an accredited smoking cessation trainer, with experience specifically related to smoking in pregnancy.

Resources provided for their ongoing use will include: 11 short videos demonstrating critical techniques in providing SCS; guidance on recording smoking information in eMaternity; information on NSW Quitline; summary guide of the 5As; Assist and arrange follow-up flip booklet; Helpful hints for clinicians; reference card to pin on badge holder; self-help booklet for use with women; NRT information sheets for clinicians; and NRT information for women.

All MOHMQuit-specific training sessions are intended to be provided as face-to-face group training sessions. However, this may need to be revised in light of the COVID-19 pandemic and on-line or hybrid models will be considered, depending on circumstances.

Regardless of mode of delivery, all participants will be provided with the relevant resources for use in their services.

All clinicians (midwives, Aboriginal Health Workers (AHWs), obstetricians and obstetric trainees) providing antenatal care will be asked to participate in the relevant training, and training will be offered several times at each site to maximise opportunity for participation.

Clinical Midwifery Educators (CMEs) will be provided training and resources to continue to deliver training to address issues of staff turnover or absence, in order to maximise sustainability of the intervention. The research team has developed a specific train-the-trainer resource pack for CMEs that includes all the materials used in the workshops for midwives, AHWs and obstetricians, (slides, instructional videos and printed resources) with instruction on how to run training, and how to adapt the training to different situations including for example, one-on-one support, half-hour brief team training, or the full one-day workshop. CMEs will attend the full one day training with the midwives and AHWs, and then an additional one hour training on how to provide the training themselves.

Additionally, services will be encouraged to form a ‘Community of practice’ to provide additional and ongoing peer support and encouragement. One-hour Community of Practice (CoP) meetings will be held monthly on an online platform (Teams, Skype or zoom), for ongoing support regarding the implementation of MOHMQuit across all sites. Each site will be added to the CoP meetings five weeks after training occurs at their site. The CoP meetings are designed to facilitate peer support in implementing MOHMQuit, but also include support provided by the senior CMC who is part of the research team, and senior research team members. CoP meetings will be open to all midwifery leaders (MUMs, CMCs, CMEs), obstetric leaders and clinicians (midwives, obstetricians, obstetric trainees, and Aboriginal Health Workers) who attended the training. Attendees will be invited to attend at their discretion.

Adherence to the intervention
Attendance records will be kept for the leaders’ workshop and clinicians’ training in order to be able to accurately report numbers of participants at each site and implementation outcomes such as the Reach of the intervention. Participants will be provided with attendance certificates for their professional development records.

References
Longman, J. M., et al. (2018). https://doi.org/10.1016/j.midw.2017.12.016

Longman, J. M., et al. (2021). https://doi.org/10.3390/ijerph181910522

Michie, S., Atkins, L., & West, R. (2014). The Behaviour Change Wheel - A Guide to Designing Interventions. United Kingdom: Silverback Publishing.

Passey, M. E., et al. (2020). https://doi.org/10.1186/s12884-020-02912-0

Passey, M. E., et al. (2021) https://doi.org/10.1186/s43058-021-00235-5
Intervention code [1] 322596 0
Behaviour
Intervention code [2] 322597 0
Lifestyle
Comparator / control treatment
Standard antenatal care.

This trial uses a cluster-randomised stepped-wedge design, with each service being randomised to transition from the baseline condition (standard care) to the intervention at two monthly intervals.

During the baseline period, current normal antenatal care will continue at each site. Standard care will differ at each site depending on their current usual practice. Standard care should include screening women for smoking status at booking in and may include review of smoking status at subsequent visits. For women identifying as being current smokers or having quit since becoming pregnant, standard care may include offering interventions (e.g., Quitline referrals or offering nicotine replacement therapy) at the booking in visit, and possibly also at subsequent visits. Usual practice may also differ by clinicians within sites.

Following the three-month intervention at each site, a 5 month ‘washout period’ will allow women who initiated antenatal care prior to the intervention to complete their pregnancy. In each site, follow-up data will be collected from the completion of the washout period in that site until the end of data collection at the final site. Outcome analyses will compare outcomes during the baseline and follow-up periods. Data from the intervention and washout periods will not be used for outcome analysis, but will capture trends to assess the dynamics of implementing change.
Control group
Active

Outcomes
Primary outcome [1] 330100 0
Biochemically-confirmed 7-day point prevalence abstinence at the end of pregnancy among pregnant smokers and recent quitters (women who report current smoking or having quit smoking since becoming pregnant, at antenatal booking), confirmed by salivary cotinine testing.
Timepoint [1] 330100 0
Within two weeks after giving birth.
Secondary outcome [1] 404879 0
Self-reported 7-day point prevalence abstinence among pregnant smokers and recent quitters (women who report current smoking or having quit smoking since becoming pregnant, at antenatal booking) at the end of pregnancy.
Timepoint [1] 404879 0
Within two weeks after giving birth.
Secondary outcome [2] 404880 0
Provision of smoking cessation support (SCS) as documented in electronic health records: offer of referral to a smoking cessation service including NSW Quitline, at booking visit and any subsequent visits.
Timepoint [2] 404880 0
Data for this outcome (deidentified data extracted from eMaternity for all women who gave birth at the participating sites during the study period and reported smoking or having quit since becoming pregnant at their booking visit) will be collected at all sites throughout the 32-month collection period. Baseline data will be collected for each site from six months prior to commencing the intervention in the first site, until the beginning of the intervention period for each site. In each site, follow-up data will be collected from the completion of the washout period in that site until the end of data collection at the final site.
Secondary outcome [3] 404881 0
Provision of smoking cessation support (SCS) as documented in electronic health records: offer of behavioural support recorded at booking visit and any subsequent visits.
Timepoint [3] 404881 0
Data for this outcome (deidentified data extracted from eMaternity for all women who gave birth at the participating sites during the study period and reported smoking or having quit since becoming pregnant at their booking visit) will be collected at all sites throughout the 32-month collection period. Baseline data will be collected for each site from six months prior to commencing the intervention in the first site, until the beginning of the intervention period for each site. In each site, follow-up data will be collected from the completion of the washout period in that site until the end of data collection at the final site.
Secondary outcome [4] 404882 0
Provision of smoking cessation support (SCS) as documented in electronic health records: offer of nicotine replacement therapy recorded at booking visit and any subsequent visit.
Timepoint [4] 404882 0
Data for this outcome (deidentified data extracted from eMaternity for all women who gave birth at the participating sites during the study period and reported smoking or having quit since becoming pregnant at their booking visit) will be collected at all sites throughout the 32-month collection period. Baseline data will be collected for each site from six months prior to commencing the intervention in the first site, until the beginning of the intervention period for each site. In each site, follow-up data will be collected from the completion of the washout period in that site until the end of data collection at the final site.
Secondary outcome [5] 404883 0
Provision of advice to quit smoking as assessed by staff self-report (study specific questionnaire).
Timepoint [5] 404883 0
Before training and 6 months post-training.
Secondary outcome [6] 404884 0
Provision of assistance to quit smoking as assessed by staff self-report (study specific questionnaire).
Timepoint [6] 404884 0
Before training and 6 months post-training.
Secondary outcome [7] 404885 0
Provision of referral to a quit smoking service (e.g., NSW Quitline or local service) as assessed by staff self-report (study specific questionnaire).
Timepoint [7] 404885 0
Before training and 6 months post-training.
Secondary outcome [8] 404886 0
Participating clinicians’ perceived capability regarding provision of guideline-recommended SCS to pregnant women as assessed by staff self-report (validated study specific questionnaire).
Timepoint [8] 404886 0
Before training, immediately post-training and 6 months post-training.
Secondary outcome [9] 404887 0
Participating clinicians’ perceptions of their work environment in enabling provision of guideline-recommended SCS to pregnant women as assessed by staff self-report (validated study specific questionnaire).
Timepoint [9] 404887 0
Before training and 6 months post-training.
Secondary outcome [10] 404888 0
Participating clinicians’ perceived priority for providing guideline-recommended SCS to pregnant women as assessed by staff self-report (validated study specific questionnaire).
Timepoint [10] 404888 0
Before training, immediately post-training and 6 months post-training.
Secondary outcome [11] 404889 0
Advice on quitting as assessed by patient self-report (study specific interview questionnaire).
Timepoint [11] 404889 0
Within two weeks after giving birth.
Secondary outcome [12] 404890 0
Referral to a quitting program as assessed by patient self-report (study specific interview questionnaire).
Timepoint [12] 404890 0
Within two weeks after giving birth.
Secondary outcome [13] 404891 0
Provision of written self-help resources on quitting as assessed by patient self-report (study specific interview questionnaire).
Timepoint [13] 404891 0
Within two weeks after giving birth.
Secondary outcome [14] 404892 0
Cost-effectiveness – the incremental cost per additional quitter from a service-provider perspective. Data will be sourced from project and site records as well as the existing literature.
Timepoint [14] 404892 0
Data collection throughout the study, with analysis at the end.
Secondary outcome [15] 404893 0
Cost-effectiveness – lifetime analysis of the incremental cost per Quality Adjusted Life Year gained. Data will be sourced from project and site records as well as the existing literature.
Timepoint [15] 404893 0
Data collection throughout the study, with analysis at the end.
Secondary outcome [16] 404894 0
Process evaluation – leader implementation of specified activities – running eMaternity reports, clinic audit and action planning, additional training on smoking cessation, developing a smoking care pathway, creating/supporting smoking cessation champions, as assessed by leader self-report (study specific questionnaire).
Timepoint [16] 404894 0
Three months after leader training.
Secondary outcome [17] 404895 0
Process evaluation – leader self-assessment of leadership related to enabling the MOHMQuit intervention (all leaders involved in the intervention) (study specific questionnaire using the Implementation Leadership Scale).
Timepoint [17] 404895 0
Three months after leader training.
Secondary outcome [18] 404896 0
Process evaluation – Perceptions of acceptability, appropriateness, feasibility of implementation, adaptations and sustainability of the MOHMQuit intervention, as assessed by qualitative interviews (using a semi-structured interview guide) with key informants.
Timepoint [18] 404896 0
Six months after leader training.

Eligibility
Key inclusion criteria
There are three groups of participants in this study :
• Pregnant/post-partum women who birth at the participating sites and meet the criteria below
• Maternity service leaders
• Maternity clinicians - midwives, Aboriginal health workers (AHWs), obstetricians and obstetric trainees.

Pregnant/post-partum women will be eligible if they:
• received antenatal care through participating maternity services
• birthed their baby at one of the participating services during the study period
• indicated that they were smokers or quit during this pregnancy at their first antenatal appointment with a health care practitioner at the participating maternity services, as recorded in eMaternity.

Eligibility of maternity service leaders and maternity care clinicians
Inclusion criteria: The following clinicians working in public maternity care services at participating sites will be eligible to participate.
1. Maternity service leaders: All maternity service leaders who support or supervise clinicians providing antenatal care (ANC) at each site, its catchment and associated services, will be eligible. These include Clinical Midwifery Consultants, Maternity Unit Managers, Clinical Midwifery Educators, Clinical Midwifery Specialists, Clinic Coordinators, Obstetric Leads, and others in leadership positions (these may vary slightly by site).
2. Maternity care clinicians: All clinicians providing antenatal care (including midwives, obstetricians, obstetric trainees and AHWs) will be eligible to participate.

**Note - managers and clinicians of both genders will be eligible to participate, but 'females' was chosen in the 'gender' question below to refer to the pregnant/postpartum women participants. Similarly, we expect clinicians to be well over 16 years of age, but the minimum age of 16 years refers to the women participants, who need to be 16 years and over at the time of recruitment during pregnancy.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria of pregnant/post-partum women:
Pregnant women receiving antenatal care at participating sites will be excluded from the study if:
• they indicate they wish to opt-out from the study
• they experience a perinatal death in this pregnancy or birth
• their baby is transferred to a Neonatal Intensive Care Unit (NICU)
• they do not speak English
• they are less than 16 years of age at the time of data collection
• the Research Midwife conducting the postnatal telephone interview assesses that they are unable to provide informed consent

Exclusion criteria of maternity service leaders and maternity care clinicians:
Maternity service leaders and maternity care clinicians will be excluded from participating if they do not work in the public maternity care services at participating sites.

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)
Allocation is not concealed (due to randomisation at the service level).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The stepped wedge cluster randomised trial design includes random allocation of services to the intervention order. An independent statistician will perform the random allocation to ensure no service is unjustifiably favoured by receiving the intervention before another service.

MOHMQuit is a stepped wedge cluster randomised trial of an implementation intervention of best practice cessation care versus treatment as usual in nine public Australian maternity care services. All services begin as part of the control condition and are block-randomised. At each intervention ‘step’, one site will be selected at random to commence the intervention. Services will be randomly allocated to ‘step’ i.e., time of commencement of the intervention phase, by an independent statistician. The study design was chosen because the intervention involves the implementation of smoking cessation care as routine practice for all pregnant women who smoke or have recently quit, and the intervention is at the service level.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
The MOHMQuit trial is a stepped wedge cluster-randomised trial. In a stepped wedge design, all sites begin in the control condition and then move to the intervention condition at randomised intervals. During the control phase, all pregnant women patients will receive ‘treatment as usual’. At randomised intervals across the study, researchers will provide sites with training and other support in the MOHMQuit intervention. Following this, all pregnant patients will receive the ‘intervention’.

From November 2022, one of the nine sites informed the research team that they were unable to continue as a test site due to severe, ongoing staffing shortages, and being unable to release clinicians to participate in the MOHMQuit training. However, this site agreed to stay in the trial as a permanent control site. Their decision to remain in the MOHMQuit trial as a control site occurred after continuous baseline data collection commenced, and before implementation at their site was due to occur.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical Power:
The trial aims to recruit 4320 pregnant women who smoke over the 32 months of data collection across the nine sites. NSW Health data indicate there were over 2000 women smoking in the first half of pregnancy in the participating sites in 2018. Assuming that at each of the 9 sites on average 40 participants will consent every 2 months, the total sample size available will be 9*40*12 = 4320. Using a significance level of 5% and assuming an intra cluster correlation (ICC) of 0.02 and a cluster autocorrelation of 0.7, the primary analysis will have more than 80% power to detect an increase in 7-day point prevalence abstinence of 5% from a baseline prevalence of 16% (i.e., intervention 21% vs control 16%). This conservative estimate is based on the effectiveness of antenatal psychosocial smoking cessation interventions in the latest Cochrane review (RR 1.44, 95%CI 1.19-1.73) (Chamberlain et al., 2017).

Analyses:
Independent and blinded statisticians from the CReDITSS Unit at the Hunter Medical Research Institute, Australia; supervised by CI Barker, will conduct analyses of the primary outcome and the secondary outcomes with the exception of the economic evaluation and the qualitative data.

Primary outcome and secondary outcome 1: The primary analysis will compare the relative odds of quitting smoking (cotinine-confirmed 7-day point prevalence abstinence) after the adoption of the intervention relative to the baseline rate. To achieve this, logistic regression will be used within a generalised linear mixed model (GLMM) framework. In addition to the fixed effect for intervention, a fixed effect for time will be included to adjust for any secular trends in the outcome. Random effects for site and time within site will be included to account for clustering by site and repeated measures over time.

For the analysis for the primary outcome, women who do not complete the biochemical verification will be classified as continuing smokers.

For the 1st secondary outcome (self-reported cessation) women who do not complete the biochemical verification, but report quitting, will be classified as having quit.

Secondary outcomes:
Secondary outcomes 2 to 4: Provision of documented smoking cessation support will be modelled using logistic regression in a GLMM framework. Fixed effects for time and intervention will be included in the model and a random effects for site and participant will be used to account for randomisation by cluster and repeated measures on participants.

Secondary outcomes 5 to 7: Post intervention clinician SCS scores will be modelled using a linear mixed model. Fixed effects will be included in the model for the pre-intervention SCS score and time. A random effect will be included for site to account for randomisation by cluster.

Secondary outcomes 8 to 10: The total scores on capability, work environment and personal priority will be modelled using two separate linear mixed models; one with the score immediately post intervention and the other with the score 6 months after intervention. Both models will adjust for pre-intervention total score and time. A random effect will be included for site to account for randomisation by cluster.

Secondary outcomes 11-13: Receipt of SCS reported by women will be modelled using logistic regression in a GLMM framework. Fixed effects for time and intervention will be included in the model and a random effect for site will be used to account for randomisation by cluster.

Secondary outcomes 14-15: Cost-effectiveness - A decision analytic model will be developed to estimate the cost-effectiveness of MOHMQuit compared to standard practice from the Australian healthcare payer perspective. Results will be the incremental cost-effectiveness ratio presented as a cost per additional pregnant woman quitting smoking for at least the 7 days prior to the birth. The robustness of the cost-effectiveness analysis will be explored using probabilistic sensitivity analysis and expressed in a Cost-Effectiveness Acceptability Curve. Sensitivity analyses will include examining uncertainty around the primary endpoint costs, and the fidelity of implementation, as well as the impact of economies of scale if the intervention was rolled out at the population level.

The time horizon for the lifetime economic model is lifetime of both the mother and the child. Costs and effects will be discounted at 5% annually. While the within trial analysis above only considers the costs and effects of the pregnant women and neonatal costs, the lifetime model will also include the costs and effects related to the child and will adapt a published probabilistic decision analytic Markov model, the Economics of Smoking in Pregnancy (ESIP) model. The ESIP model captures both the lifetime costs and outcomes of the mother and the lifetime costs and outcomes of the child. This has the benefit of capturing the benefits of stopping smoking which occur beyond the short time horizon of the within trial cost effectiveness analysis.

Secondary outcomes 16-17: Descriptive analysis (scores and proportions) will be undertaken to summarise results by site.

Qualitative evaluation
All interviews with maternity service leaders will be audio recorded, transcribed (with permission), and a general inductive approach will be taken to the analysis. An interview guide will be used. It is anticipated that most interviews will be conducted remotely using telephone or video-conferencing technology.

Reference cited:
Chamberlain, C., O'Mara-Eves, A., Porter, J., Coleman, T., Perlen, S. M., Thomas, J., & McKenzie, J. E. (2017). Psychosocial interventions for supporting women to stop smoking in pregnancy. The Cochrane Library.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
4/05/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
4320
Accrual to date
2946
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21460 0
Grafton Base Hospital - Grafton
Recruitment hospital [2] 21461 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [3] 21462 0
Orange Health Service - Orange
Recruitment hospital [4] 21463 0
Griffith Base Hospital - Griffith
Recruitment hospital [5] 21464 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [6] 21465 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 21466 0
Shoalhaven Hospital - Nowra
Recruitment hospital [8] 21467 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 23855 0
Bathurst Base Hospital - Bathurst
Recruitment postcode(s) [1] 36363 0
2460 - Grafton
Recruitment postcode(s) [2] 36364 0
2830 - Dubbo
Recruitment postcode(s) [3] 36365 0
2800 - Orange
Recruitment postcode(s) [4] 36366 0
2680 - Griffith
Recruitment postcode(s) [5] 36367 0
2650 - Wagga Wagga
Recruitment postcode(s) [6] 36368 0
2500 - Wollongong
Recruitment postcode(s) [7] 36369 0
2541 - Nowra
Recruitment postcode(s) [8] 36370 0
2747 - Kingswood
Recruitment postcode(s) [9] 39313 0
2795 - Bathurst

Funding & Sponsors
Funding source category [1] 310534 0
Government body
Name [1] 310534 0
National Health and Medical Research Council (NHMRC)
Country [1] 310534 0
Australia
Funding source category [2] 310537 0
Government body
Name [2] 310537 0
NSW Ministry of Health
Country [2] 310537 0
Australia
Funding source category [3] 310538 0
Charities/Societies/Foundations
Name [3] 310538 0
Cancer Council NSW
Country [3] 310538 0
Australia
Funding source category [4] 310539 0
Government body
Name [4] 310539 0
Cancer Institute NSW
Country [4] 310539 0
Australia
Funding source category [5] 310540 0
Government body
Name [5] 310540 0
Illawarra Shoalhaven Local Health District (IS LHD)
Country [5] 310540 0
Australia
Funding source category [6] 310541 0
Government body
Name [6] 310541 0
Murrumbidgee Local Health District (MLHD)
Country [6] 310541 0
Australia
Funding source category [7] 310542 0
Government body
Name [7] 310542 0
Nepean Blue Mountains Local Health District (NBM LHD)
Country [7] 310542 0
Australia
Funding source category [8] 310543 0
Government body
Name [8] 310543 0
Northern New South Wales Local Health District (NNSW LHD)
Country [8] 310543 0
Australia
Funding source category [9] 310544 0
Government body
Name [9] 310544 0
Western NSW Local Health District (WNSW LHD)
Country [9] 310544 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University Centre for Rural Health
The University of Sydney
61 Uralba St
Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 311711 0
None
Name [1] 311711 0
Address [1] 311711 0
Country [1] 311711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310157 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 310157 0
Ethics committee country [1] 310157 0
Australia
Date submitted for ethics approval [1] 310157 0
31/05/2021
Approval date [1] 310157 0
23/07/2021
Ethics approval number [1] 310157 0
2021/ETH00887
Ethics committee name [2] 314524 0
AH&MRC Aboriginal Health & Medical Research Council of NSW
Ethics committee address [2] 314524 0
Ethics committee country [2] 314524 0
Australia
Date submitted for ethics approval [2] 314524 0
18/12/2023
Approval date [2] 314524 0
Ethics approval number [2] 314524 0

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

Contacts
Principal investigator
Name 116686 0
Prof Megan Passey
Address 116686 0
University Centre for Rural health
The University of Sydney
61 Uralba St
Lismore
NSW 2480
Country 116686 0
Australia
Phone 116686 0
+61 429 651 245
Fax 116686 0
Email 116686 0
[email protected]
Contact person for public queries
Name 116687 0
Larisa Barnes
Address 116687 0
University Centre for Rural health
The University of Sydney
61 Uralba St
Lismore
NSW 2480
Country 116687 0
Australia
Phone 116687 0
+61 432 730 407
Fax 116687 0
Email 116687 0
[email protected]
Contact person for scientific queries
Name 116688 0
Megan Passey
Address 116688 0
University Centre for Rural health
The University of Sydney
61 Uralba St
Lismore
NSW 2480
Country 116688 0
Australia
Phone 116688 0
+61 429 651 245
Fax 116688 0
Email 116688 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
The datasets generated and/or analysed during the current study are not publicly available because participants in the study, and data custodians of the administrative data extracted from eMaternity (e-medical record system) did not give permission for sharing of the data.


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.