Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001204639p
Ethics application status
Submitted, not yet approved
Date submitted
6/09/2023
Date registered
22/11/2023
Date last updated
22/11/2023
Date data sharing statement initially provided
22/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
RISE SAFELY in rural Australia - Redesigning maternity services for Aboriginal mothers and babies who are accessing care at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales, using Birthing on Country principles and the RISE implementation Framework, to address preterm birth and health outcomes: A prospective, non-randomised, intervention trial.
Scientific title
Investigating the effect of Birthing on Country redesign on maternal and infant health outcomes, including preterm birth for Aboriginal mothers and babies who are accessing care at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales, compared to concurrent control: A prospective, non-randomised, intervention trial.
Secondary ID [1] 310413 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 331171 0
Infant Health 331172 0
Maternal Health 331173 0
Condition category
Condition code
Public Health 327943 327943 0 0
Health service research
Reproductive Health and Childbirth 327944 327944 0 0
Antenatal care
Reproductive Health and Childbirth 327945 327945 0 0
Breast feeding
Reproductive Health and Childbirth 327946 327946 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 327947 327947 0 0
Complications of newborn
Reproductive Health and Childbirth 327948 327948 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 'Birthing on Country' service will be established at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales, a rural demonstration site. The new model is going to be ongoing from 2024. We will partner with key stakeholders through our community-based Participatory Action Research (PAR) approach to redesign a rural maternity service and increase support for Aboriginal women in both the primary and tertiary setting. The intervention is commenced at the first visit to the Minga Gudjaga midwifery service. Co-design and planning for the new model, including the development of operational plans, transitional plans, risk assessment, workshops has been happening for several years (during the previous study Building on our Strengths).

Key components of the intervention include:
- Multi-agency Partnership Committee providing culturally responsive overarching governance and leadership of redesign of maternity services and research, community engagement in co-designing the new model of care.
- Service redesign will be overseen by the Birthing on Country Executive Steering Committee with members from Waminda, My Midwives and ISLHD; a Cultural and Clinical Governance Committee with members from Waminda, My Midwives and ISLHD and an internal Waminda BOC Implementation Steering Group.
- Antenatal care is provided by Waminda’s Minga Gudjaga Midwifery Group Practice within the Minga Gudjaga Gunyah clinic, the woman’s home or hospital environment, and in the future this will be located at the Gudjaga Gunyahlamai Birth Centre.
- Aboriginal Health Practitioners will provide continuity of care, cultural and clinical support across the antenatal, intrpartum and postnatal engagement.
- Antenatal care using Aboriginal knowledges will be co-designed to address modifiable preterm risk factors.
- Midwives follow the National Midwifery Guidelines for Consultation and Referral. When women are Categorised as B (midwives consult with the obstetric staff at the hospital or GP at Waminda, depending on the condition). When women are Category C, midwives consult with the specialist at the hospital to plan a specialist antenatal appointment and ongoing care at Shoalhaven District Memorial Hospital (SDMH) however women will continue to receive continuity of care by their named midwife and receive specialist input as required (E.g. diabetes educator). Women have 24/7 phone access to a known Waminda midwife.
- Minga Gudjaga Midwives will collaborate with a nominated O&G Consultant within the Minga Gudjaga Gunyah clinic and in the future the Gudjaga Gunyahlamai Birth Centre.
- An Aboriginal Community Controlled Midwifery Group Practice that employs Endorsed Midwives will be established at Waminda. This will establish and embed a unique model of continuity of maternity care that sits within the service provision and model of care within Waminda.
- After birth, when the women and baby return to the community, the primary midwife and Waminda support services provide postnatal care for up to 6-weeks after which time Waminda’s early childhood services continue care.
- Waminda uses Communicare, which is a community-based system of formal clinical communication, which differs from the existing systems within SDMH. This places a communication burden on the midwives as they will be required to document in two communication systems.
- Women are referred to Waminda support services in line with guidelines. Aim is to recruit and embed 1-2-student midwives into this service.
- Aboriginal health practitioner embedded within the model will be the first point of contact within the maternity journey for all women.
- Transport officer for women who require assistance.
- Frontline staff are provided with clinical mentoring and reflective supervision with a focus on clinical and cultural safety, effective intercultural communication, and working together.
- The Wiyana Yanaga (Cultural Framework) is the foundation of Waminda. Informing this is the Waminda Cultural Committee, made up of local Aboriginal women who represent many family bloodlines who guide and inform all practices and protocols at Waminda.
- The Birthing on Country Manager providing cultural and operational leadership.
- Non-Aboriginal staff attend monthly ‘Imperfect Allies’ groups to support continual self-reflection of their white privilege to ensure they are working safely with Koori staff and clients.
- A community-based hub provides a culturally responsive and safe place for women, families, caregivers and Elders to undertake cultural activities that allow connection, sharing and learning from each other within a strength-based approach to birthing and parenting. Monthly drop in.
- Aboriginal women and their babies are offered cultural ceremonies after the birth of their baby.
- Support from Waminda programs, including family restoration and preservation services, diabetes educator, exercise physiologist, health and wellbeing services, healing programs, general case management.
Intervention code [1] 326812 0
Treatment: Other
Comparator / control treatment
All women who carry an Aboriginal baby/babies and gave birth at Illawarra Shoalhaven Local Health District and do not receive Waminda maternity care is defined as concurrent control cohort (2024-2027). Data will be collected from Waminda Communicare database and Illawarra Shoalhaven Local Health District Hospital Perinatal Data Collection.

Characteristics of standard care:
- No Aboriginal oversight of maternity services
- Antenatal care is provided at the hospital, by midwives, general practitioners or by the Aboriginal Maternal Infant Health Strategy teams.
- Aboriginal Maternal and Infant Health Service Aboriginal Health Workers provide community education support and care. They do not provide clinical care.
- Midwives at the hospital follow hospital guidelines. When women are receiving care from the GP they follow their own guidelines. No 24/7 phone access to a known (primary) midwife.
- Clinical care for women in labour is provided from a roster of midwives and may be a midwife the woman has never met.
- After birth, when the women and baby return to the community, postnatal care may be provided by the hospital or Waminda.
- Services communicate with referrals and discharge summaries via electronic mail (+/-phone). These are often missing or late.
- After birth, when women and baby return to the community they will receive postnatal care up to 2 weeks. After which time they hand over to child and family health service.
- Written handover of care for transfer between services.
- Women are referred to Aboriginal support services within the community, such as AMIHS and AMS.
- No ongoing provision of mentoring and reflective supervision.
- Aboriginal liaison officer and social worker available on referral.
- Some women have access to a community-based hub.
Control group
Active

Outcomes
Primary outcome [1] 335805 0
Proportion of women giving birth preterm (at least 20-weeks’ gestation or 400 grams birthweight and <37-weeks’ gestation). This outcome will be assessed via audit of patient medical records.
Timepoint [1] 335805 0
At birth.
Primary outcome [2] 335807 0
Proportion of low-birth-weight babies (< 2500g). This outcome will be assessed via audit of patient medical records.
Timepoint [2] 335807 0
At birth.
Primary outcome [3] 335808 0
Proportion of women who received an epidural in labour. This outcome will be assessed via audit of patient medical records.
Timepoint [3] 335808 0
At birth.
Secondary outcome [1] 425720 0
Primary Outcome: proportion of women who had a Spontaneous vaginal birth. This outcome will be assessed via audit of patient medical records.
Timepoint [1] 425720 0
At birth.
Secondary outcome [2] 425721 0
Primary Outcome: proportion of women who had an elective caesarean section. This outcome will be assessed via audit of patient medical records.
Timepoint [2] 425721 0
At birth.
Secondary outcome [3] 425722 0
Primary outcome: proportion of babies that were admitted to the neonatal nursery before discharge from hospital following birth. This outcome will be assessed via audit of patient medical records.
Timepoint [3] 425722 0
At discharge from hospital.
Secondary outcome [4] 425723 0
Primary Outcome: proportion of women that were exclusively breastfeeding at discharge. This outcome will be assessed via audit of patient medical records.
Timepoint [4] 425723 0
At discharge from hospital.
Secondary outcome [5] 425724 0
Proportion of women who have their first antenatal contact within 1st trimester (<14 weeks). This outcome will be assessed via audit of patient medical records.
Timepoint [5] 425724 0
At birth.
Secondary outcome [6] 425725 0
Antenatal care attendance (5 or more visits, <5 visits) at birth. This outcome will be assessed via audit of patient medical records.
Timepoint [6] 425725 0
At birth.
Secondary outcome [7] 425726 0
The following secondary outcomes will be assessed separately: Smoking in pregnancy (yes/no); Alcohol consumptions in pregnancy (yes/no); Illicit drugs usage at third trimester (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [7] 425726 0
Birth.
Secondary outcome [8] 425727 0
The following secondary outcomes will be assessed separately: Waminda MGP staff present during labour (yes/no); Waminda MGP staff present during birth (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [8] 425727 0
Birth.
Secondary outcome [9] 425728 0
The following secondary outcomes will be assessed separately: Primary midwife present during labour (yes/no); Primary midwife present during birth (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [9] 425728 0
Birth.
Secondary outcome [10] 425729 0
Pregnancy-induced hypertension (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [10] 425729 0
Birth.
Secondary outcome [11] 425730 0
Antepartum haemorrhage (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [11] 425730 0
Birth
Secondary outcome [12] 425731 0
Gestational diabetes (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [12] 425731 0
Birth.
Secondary outcome [13] 425732 0
Analgesia in labour (regional analgesia [epidural/spinal], narcotic analgesia, nitrous oxide gas). This outcome will be assessed via audit of patient medical records.
Timepoint [13] 425732 0
Birth.
Secondary outcome [14] 425733 0
The following secondary outcomes will be assessed separately: Onset of labour (induced, no labour, spontaneous); Augmentation of labour (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [14] 425733 0
Birth.
Secondary outcome [15] 425734 0
Mode of birth (non-instrumental vaginal birth, instrumental vaginal birth, caesarean section). This outcome will be assessed via audit of patient medical records.
Timepoint [15] 425734 0
Birth.
Secondary outcome [16] 425736 0
Vaginal birth after caesarean section. This outcome will be assessed via audit of patient medical records.
Timepoint [16] 425736 0
Birth.
Secondary outcome [17] 425737 0
The following secondary outcomes will be assessed separately: Perineal status (intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear); Episiotomy (yes/no). Each outcome will be assessed by audit of patient medical records.
Timepoint [17] 425737 0
Birth.
Secondary outcome [18] 425738 0
Normal birth (>=37 weeks, vertex presentation, spontaneous onset of labour, no regional analgesia, spontaneous vaginal birth, no episiotomy). This outcome will be assessed via audit of patient medical records.
Timepoint [18] 425738 0
Birth.
Secondary outcome [19] 425739 0
The intended place of birth at booking. This outcome will be assessed via audit of patient medical records.
Timepoint [19] 425739 0
Birth.
Secondary outcome [20] 425740 0
The place of birth. This outcome will be assessed via audit of patient medical records.
Timepoint [20] 425740 0
Birth.
Secondary outcome [21] 425742 0
Born before arrival (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [21] 425742 0
Birth.
Secondary outcome [22] 425743 0
Separation mode of mother (Discharged to usual residence, Transfer to another hospital, Died, Left against advice, Other, Unknown). This outcome will be assessed via audit of patient medical records.
Timepoint [22] 425743 0
At discharge from hospital following birth.
Secondary outcome [23] 425744 0
Neonatal outcome at birth (livebirth, stillbirth). This outcome will be assessed via audit of patient medical records.
Timepoint [23] 425744 0
Birth.
Secondary outcome [24] 425745 0
Respiratory neonatal resuscitation (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [24] 425745 0
Birth.
Secondary outcome [25] 425746 0
Apgar score at 5 minutes (<7, >=7). This outcome will be assessed via audit of patient medical records.
Timepoint [25] 425746 0
5 minutes after birth.
Secondary outcome [26] 425747 0
Infant admission to hospital up to 28 days of age (yes/no). This outcome will be assessed via audit of patient medical records.
Timepoint [26] 425747 0
28 days post birth.
Secondary outcome [27] 425748 0
Mode of separation of baby from hospital of birth (Discharge to usual residence, Transfer to another acute hospital, Transfer to another acute hospital and died, Stillborn/Neonatal death (hospital of birth), Other). This outcome will be assessed via audit of patient medical records.
Timepoint [27] 425748 0
At discharge from hospital following birth.
Secondary outcome [28] 425749 0
The following secondary outcomes will be assessed separately: Mother’s and infant’s duration of total stay in hospital (mean, median, range); Length of facility stay for mothers and infants following birth. Each outcome will be assessed by audit of patient medical records.
Timepoint [28] 425749 0
At discharge from hospital following birth.
Secondary outcome [29] 425750 0
Healthy baby (live born, singleton, >=37 weeks gestation, 2,500-4,499g birthweight, Apgar score at five minutes 7 or higher). This outcome will be assessed via audit of patient medical records.
Timepoint [29] 425750 0
5 minutes after birth.
Secondary outcome [30] 425751 0
Referral to NSW Department of Community and Justice (DCJ) in pregnancy. This outcome will be assessed via audit of patient medical records.
Timepoint [30] 425751 0
Birth.
Secondary outcome [31] 425752 0
Referral to Case Management in pregnancy. This outcome will be assessed via audit of patient medical records.
Timepoint [31] 425752 0
birth.
Secondary outcome [32] 425753 0
Child Safety unborn notification and child removal up to 28 days. This outcome will be assessed via audit of patient medical records.
Timepoint [32] 425753 0
28 days post birth.
Secondary outcome [33] 425754 0
Referral to Nabu. This outcome will be assessed via audit of patient medical records.
Timepoint [33] 425754 0
28 days post birth.
Secondary outcome [34] 425755 0
Referral to Empwering Mothers and Babies Autonomy (EMBA). This outcome will be assessed via audit of patient medical records.
Timepoint [34] 425755 0
28 days post birth.
Secondary outcome [35] 425756 0
Referral to transport. This outcome will be assessed via audit of patient medical records.
Timepoint [35] 425756 0
28 days post birth.
Secondary outcome [36] 426136 0
Incremental cost-effectiveness ratio (ICER). The total costs from 1st presentation to 6 weeks after birth including antenatal costs, birthing costs, postnatal costs and neonatal costs, for both intervention and control, will be estimated. Data will be sourced from routinely collected medical records. The effect will be measured in terms of preterm birth rate.
Timepoint [36] 426136 0
42 days post birth.
Secondary outcome [37] 426438 0
Primary postpartum haemorrhage (500ml or more within 24 hours of birth).
Timepoint [37] 426438 0
24 hours post birth. We are relying on what is recorded in the midwives database, this usually occurs within the first 4 hours of birth and is documented before women leave the birthing environment.
Secondary outcome [38] 427219 0
Number of antenatal visits by Aboriginal Health Practitioner. This will be recorded in the Communicare database - we have created a new clinical item for this variable.
Timepoint [38] 427219 0
Birth
Secondary outcome [39] 427220 0
Number of postnatal visits by Aboriginal Health Practitioner. This will be recorded in the Communicare database - we have created a new clinical item for this variable.
Timepoint [39] 427220 0
42 days post birth.

Eligibility
Key inclusion criteria
All women who are registered in the Waminda database as receiving antenatal care (including women who have recorded a miscarriage or a termination of pregnancy) and those who have given birth to an Aboriginal baby, during the study period is defined as: intervention cohort (2024-2027) vs all other women who carry an Aboriginal baby/babies and gave birth at Illawarra Shoalhaven Local Health District as concurrent control cohort (2024-2027).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who did not carry an Aboriginal baby will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
A prospective, non-randomised, intervention trial will be conducted to assess and report the clinical effectiveness of the new service on key maternal and infant health outcomes compared to the control group.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will compare the difference in maternal and child health outcomes between the intervention and control cohorts. Initial bivariate analysis will investigate possible differences between the cohorts for baseline socio-demographic (socio-economic status), and clinical characteristics (e.g. age, parity, BMI, smoking, obstetric history etc) that could affect outcomes. Dependent on data type, preliminary analysis will be undertaken using independent samples t-tests, Mann-Whitney U tests or Chi-squared tests. Descriptive statistics will be reported as: means and standard deviations for continuous variables and number and percentages for categorical variables. For the formal modelling, linear regression will be employed for continuous outcomes, and logistic regression will be used for categorical outcomes (binary, multinomial and ordinal) yielding odds ratios and their 95% confidence intervals. All unadjusted effects will be generated using bivariate regression models (linear or logistic, as appropriate) whereas adjusted effect sizes will be estimated using propensity score analysis. Any confounders identified from the literature and our previous studies will be adjusted. Analysis will be performed with Stata or R and statistical significance is set as p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
972
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25409 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 41149 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 314622 0
Government body
Name [1] 314622 0
NHMRC
Country [1] 314622 0
Australia
Primary sponsor type
University
Name
Charles Darwin University
Address
Ellengowan Drive, Casuarina, NT 0810, Australia
Country
Australia
Secondary sponsor category [1] 316584 0
None
Name [1] 316584 0
Address [1] 316584 0
Country [1] 316584 0
Other collaborator category [1] 282798 0
Other Collaborative groups
Name [1] 282798 0
Waminda South Coast Women's Health and Wellbeing Aboriginal Corporation
Address [1] 282798 0
122 Kinghorne St, Nowra NSW 2541
Country [1] 282798 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313645 0
Aboriginal Health and Medical Research Council Human Research Ethics Committee
Ethics committee address [1] 313645 0
Ethics committee country [1] 313645 0
Australia
Date submitted for ethics approval [1] 313645 0
19/09/2023
Approval date [1] 313645 0
Ethics approval number [1] 313645 0

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

Contacts
Principal investigator
Name 128858 0
Prof Yvette Roe
Address 128858 0
Molly Wardaguga Reseach Centre, Charles Darwin University, Ellengowan Drive, Casurarina NT 0810
Country 128858 0
Australia
Phone 128858 0
+61 88946 7668
Fax 128858 0
Email 128858 0
[email protected]
Contact person for public queries
Name 128859 0
Yvette Roe
Address 128859 0
Molly Wardaguga Reseach Centre, Charles Darwin University, Ellengowan Drive, Casurarina NT 0810
Country 128859 0
Australia
Phone 128859 0
+61 88946 7668
Fax 128859 0
Email 128859 0
[email protected]
Contact person for scientific queries
Name 128860 0
Sue Kildea
Address 128860 0
Molly Wardaguga Research Centre, Charles Darwin University, 10 Grevillea Drive Sadadeen NT 0870
Country 128860 0
Australia
Phone 128860 0
+61 418289199
Fax 128860 0
Email 128860 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 individual data of published results only.
When will data be available (start and end dates)?
The data will be available at the discretion of the Project Reference Group at the end of the study and 5-years after publication of the primary outcomes paper (estimated in 2029).
Available to whom?
Case-by-case basis at the direction of Chief Investigator and Project Reference Group.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
The datasets generated and/or analysed during the current study may be available from the Chief Investigator ([email protected] and [email protected]) on reasonable request pending approval by the Project Reference Group to ensure Aboriginal data sovereignty guidelines are adhered to.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20057Study protocol  [email protected]
20058Statistical analysis plan  [email protected]
20059Ethical approval  [email protected]



Results publications and other study-related documents

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