ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000939392

Ethics application status

Not required

Date submitted

13/04/2026

Date registered

29/07/2026

Date last updated

29/07/2026

Date data sharing statement initially provided

29/07/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

Healthy Mums and Bubs - Birthing in Our Community (BiOC): Gold Standard Indigenous Maternal & Infant care

Scientific title

LEWIS - LEarning, Wondering and Inquiring Leading System reform and elevating family health and wellbeing: Effect of Birthing in Our Community on antenatal and birth outcomes of women and their Aboriginal and/or Torres Strait Islander babies

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

LEWIS

Related trial records

Health condition

Health condition(s) studied:

Culturally appropriate perinatal health and wellbeing

Socioemotional wellbeing

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Public Health

Health service research

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

A successful Birthing in our Community program (BiOC) program has been established in one site and it is being scaled up to further 3 sites, with the health outcomes of mother-baby dyads being compared against the outcome of the original comparator site along with program acceptability.

Therefore, the focus of the current study is to extend the reach of the BiOC program by expanding the service to three other sites (Logan, Bayside and Brisbane North) while continuing the original BiOC South comparator site/service, and follow cohorts of families to assess clinical outcomes and program acceptability up to three months postnatally.

Background:
Initially established in 2013 in the south of Brisbane (QLD, Australia) by the Institute for Urban Indigenous Health (IUIH), together with its partner organisation - the Mater Mothers Hospital, BiOC is an Aboriginal and Torres Strait Islander-designed and led maternity care and family support program, The BiOC program now provides services across Southeast Queensland at 3 additional sites (the intervention) for pregnant women with Aboriginal and Torres Strait Islander babies access to a midwife, family support worker and multidisciplinary team for the duration of their pregnancy and birth and post-partum.

BiOC core elements include:
- access to a birthing facility, specialist obstetric services, outreach (allied health) services, and social health services (social work, psychology, parenting support, support with child safety matters)
– Intrapartum care is provided in partnering birthing facilities.
- Community-based hubs facilitate access to antenatal and postnatal care in a culturally safe environment:
Parenting and cultural support are integrated into all elements of the services with the Community Hub offering a ‘no wrong door’ and ‘one stop shop’ approach to service delivery.
- Visiting and/or resident on-site services may include obstetric and gynaecological services, sexual and reproductive health, adult allied health including physiotherapy, exercise physiology, dietician, and diabetes educator; psychosocial services including social worker, perinatal psychologist, and counselling services; and paediatric medical, allied health and early childhood learning services.
- Continuity of Aboriginal and Torres Strait Islander Family Support Workers (FSW): the FSW works alongside the woman’s primary midwifery carer to connect, engage and retain families in the program, gather psychosocial information, identify strengths and needs, assist families to access required services and supports, and advocate, as requested, on behalf of families.
- Continuity of midwifery care including a known midwife during pregnancy (antenatal care), during birth and early parenting (postnatal care) for at least six weeks linked to the tertiary service with specialist support when needed. The midwives work between the community-based ACCHS-owned hub (for antenatal and postnatal care, education, and yarning groups), the hospital (for birthing and specialist care), and the woman’s home (for antenatal and post-natal follow-up care as determined by the woman and her care team).

The LEWIS study has 3 separate components:
1) Quantitative Component: Quantitative comparisons of a prospective cohort of women and their families engaged in care across the four BiOC program sites. The data analysis under this component will cover the pregnancy, birthing, and postnatal periods and be focused on clinical and socio-emotional well-being outcomes. The exposure/intervention for this component will be the delivery of BiOC program and its elements.

2) Economic evaluation component: Routinely collected clinical outcomes and IUIH’s data on BiOC-related costs project expenditure data will be used for the cost-consequence analysis. The exposure/intervention for this component will be the economic cost involved in delivering the BiOC program and its elements.

3) Qualitative Component: Healing-informed, woman centred qualitative exploration of the acceptability and impact of the BiOC program among participating families and the feasibility of expanding BiOC for participating organisations including service staff. The exposure/intervention for this component will be the delivery of BiOC program and its elements.

Duration and frequency of participant engagement with BiOC Elements:
Frequency and engagement with BiOC services are determined on a needs-basis with consultation between client and service staff. Social health services are offered to BiOC families experiencing social complexities. Therefore, there are no universal frequency and duration benchmarks for these consultations. Antenatal appointment frequencies can vary depending on whether the pregnancy is considered complicated and can vary from 7-10 appointments. Clients also have the option to have their dedicated Family Support Practitioner join them in all their midwifery appointments. BiOC also offers home midwifery support up to 6 weeks post-birth, infant health checks, GP services, and dedicated family support.

Overall duration of the intervention administration:
BiOC started operating in 2013 and is being offered as an ongoing program (does not have a set end date for intervention administration). However, for the purpose of this study we will only be using the data spanning up to end of 2026 (with some variations between outcomes that are further detailed under the outcome variables section).

Method of participant allocation: Participants self select by attending the study sites.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Description of the comparator or control

The comparator site is the BiOC South hub, which is based in the Brisbane suburb of Salisbury, and the original BiOC program implemented at this site has been evaluated in an earlier study (ACTRN12618001365257).

The BiOC elements offered at the comparator site include:
- Access to a birthing facility, specialist obstetric services, outreach (allied health) services, and social health services (social work, psychology, parenting support, support with child safety matters)
– Intrapartum care
- Community-based hubs facilitate access to antenatal and postnatal care in a culturally safe environment:
Parenting and cultural support are integrated into all elements of the services with the Community Hub offering a ‘no wrong door’ and ‘one stop shop’ approach to service delivery.
- Visiting and/or resident on-site services may include obstetric and gynaecological services, sexual and reproductive health, adult allied health including physiotherapy, exercise physiology, dietician, and diabetes educator; psychosocial services including social worker, perinatal psychologist, and counselling services; and paediatric medical, allied health and early childhood learning services.
- Continuity of Aboriginal and Torres Strait Islander Family Support Workers (FSW): The FSW works alongside the woman’s primary midwifery carer to connect, engage and retain families in the program, gather psychosocial information, identify strengths and needs, assist families to access required services and supports, and advocate, as requested, on behalf of families.
- Continuity of midwifery care including a known midwife during pregnancy (antenatal care), during birth and early parenting (postnatal care) for at least six weeks linked to the tertiary service with specialist support when needed. The midwives work between the community-based ACCHS-owned hub (for antenatal and postnatal care, education, and yarning groups), the hospital (for birthing and specialist care), and the woman’s home (for antenatal and post-natal follow-up care as determined by the woman and her care team).

Similarities and differences between the BiOC elements provided at the intervention study sites and the comparator site:
i) The comparator site of BiOC South has continued with the original BiOC in partnership with the Mater Hospital. The wraparound services are provided by the BiOC hub and the midwifery care is provided by the hospital.
ii) Two new BiOC programs have been expanded as intervention in partnership between IUIH Network and Queensland public hospitals. The first one of the two - BiOC Logan is being implemented in partnership between IUIH, ATSICHS Brisbane, and Logan Hospital; and the second one – BiOC Bayside is being implemented in partnership between Yulu Burri Ba Aboriginal Corporation for Community Health (YBB) and Redlands Hospital. The wraparound services are provided by the BiOC hubs while the midwifery care is provided by the relevant public hospital.
iii) Another BiOC program in Brisbane North has involved a partnership between IUIH and MyMidwives, a private midwifery company (BiOC North). The wraparound services are provided by the BiOC hubs while the midwifery care is provided by the midwives employed by the private midwifery company.

Summary:
This implementation and evaluation research aims to assess the scalability, sustainability, acceptability, and impact of this ‘gold standard' birthing program in the three new BiOC sites, compared with the comparator site of BiOC South.

Control group

Active

Outcomes

Primary outcome [1]

Number of clinical antenatal visits during pregnancy

Timepoint [1]

Once at the end of pregnancy

Primary outcome [2]

Gestational age at birth

Timepoint [2]

At birth

Primary outcome [3]

Exclusive breastfeeding at hospital discharge

Timepoint [3]

Once at hospital discharge

Secondary outcome [1]

Gestation at 1st antenatal care (ANC) visit

Timepoint [1]

First ANC visit

Secondary outcome [2]

Emotional wellbeing

Timepoint [2]

Once during pregnancy and at six weeks post pregnancy

Secondary outcome [3]

Smoking during the first 20 weeks of pregnancy

Timepoint [3]

Once during the first 20 weeks of pregnancy

Secondary outcome [4]

Illicit/recreational drug use in pregnancy

Timepoint [4]

Duration of pregnancy

Secondary outcome [5]

Method of birth (possible methods of birth are: spontaneous vaginal, assisted vaginal, emergency Caesarean-section, or elective Caesarean-section)

Timepoint [5]

At birth

Secondary outcome [6]

Perineal trauma (third-degree or fourth-degree tear, episiotomy)

Timepoint [6]

At birth

Secondary outcome [7]

Hospital length of stay (mums)

Timepoint [7]

At the point of discharge

Secondary outcome [8]

Birthweight and birthweight Z-score

Timepoint [8]

At birth

Secondary outcome [9]

APGAR score at 5 mins. The Apgar score is calculated by assessing five criteria: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing). This study will only assess APGAR score at 5 minutes after birth and not APGAR score at 1 minute after birth.

Timepoint [9]

5 mins post-birth

Secondary outcome [10]

Admissions to special care nursery/ intensive care nursery and length of stay

Timepoint [10]

Post-birth

Secondary outcome [11]

Perinatal deaths (stillbirths and neonatal deaths)

Timepoint [11]

Post-birth

Secondary outcome [12]

Breastfeeding at hospital discharge

Timepoint [12]

Within the 24 hours preceding discharge

Secondary outcome [13]

Smoking status during after the first 20 weeks of pregnancy

Timepoint [13]

Once post 20 weeks of pregnancy

Secondary outcome [14]

Primary/repeat Caesarean (Method of delivery of last birth)

Timepoint [14]

At birth

Secondary outcome [15]

Post-partum haemorrhage

Timepoint [15]

Up to first 24 hours after birth

Secondary outcome [16]

Blood loss amount following post-partum haemorrhage

Timepoint [16]

Up to the first 24 hours after birth

Secondary outcome [17]

Cost-consequence of BiOC implementation: (This outcome is a part of LEWIS economic evaluation study)

Timepoint [17]

Cost involved in the program between 2023 and mid-2026

Secondary outcome [18]

Program acceptability for mothers and families

Timepoint [18]

Data collection done between 2024-2026

Secondary outcome [19]

Feasibility of the 4 BiOC programs - including views of service providers, and managers

Timepoint [19]

Qualitative data collection between 2024 and 2025

Secondary outcome [20]

Sustainability of the 4 BiOC programs

Timepoint [20]

Qualitative data collection between 2024 and 2025

Secondary outcome [21]

Scalability of the BiOC program to the additional 3 sites

Timepoint [21]

Qualitative data collection between 2024 and 2025

Secondary outcome [22]

Impact on BiOC families and partners (including staff)

Timepoint [22]

Qualitative data collection between 2024 and 2026

Eligibility

Key inclusion criteria

Women, aged 15 years or above, enrolled in the BiOC program will be eligible to participate in this research if they are pregnant with (or have given birth to) an Aboriginal and/or Torres Strait Islander baby; receive maternity care through a BiOC program; and consent to participate. This study is not targeting young women, however, in the previous BiOC research studies in which several of our team were involved, it was considered important not to exclude young women based on age alone (as per the National Statement). When young women are deemed to be mature enough to clearly understand what the research and research participation entails and to be free from any coercion, then parental consent will not be sought based on young women’s capacity to consent in their own right (NHMRC, 2007 chapter 4.2 (updated 2023))

FOR QUALITATIVE COMPONENT:
Apart from clients, the study also has a second participant group, i.e. staff and their inclusion criteria are as follows:
- Employed to work in BiOC program and/or responsible for overseeing BiOC program delivery
- Provides consent to participate in a yarn (qualitative interview) following a contact from the IUIH Research team

Minimum age

0 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Women having the first contact with a medical professional after 36 weeks of gestation and multiple pregnancies (for clients).

Staff not involved in the BiOC program at IUIH

Study design

Purpose of the study

Prevention

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Participants select which study site to attend

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

1/07/2022

Date of last participant enrolment

Anticipated

Actual

30/06/2026

Date of last data collection

Anticipated

31/12/2026

Actual

Sample size

Target

1800

Accrual to date

Final

2145

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health, Disability and Ageing - The Medical Research Future Fund (MRFF)

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Institute For Urban Indigenous Health Ltd (IUIH)

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Not required

Summary

Brief summary

Birthing in Our Community (BiOC) is an Aboriginal and Torres Strait Islander-designed and led maternity care and family support program initially established in 2013 in South Brisbane (QLD, Australia) by the Institute for Urban Indigenous Health (IUIH), together with its partner organisations, the Mater Mothers Hospital and the Aboriginal and Torres Strait Islander Community Health Service Brisbane (ATSICHS Brisbane, a member organisation of IUIH).  An initial evaluation of BiOC’s outcomes from 2015 - 2019 has shown a significant reduction in preterm births (between 43% and 50%) and increases in healthy-weight babies, antenatal visits, and exclusive breastfeeding at hospital discharge.
Building on the success of BiOC Brisbane South, IUIH and its member Aboriginal Community Controlled Health Services have secured resources to support the expansion of the BiOC Model into three new locations: Brisbane North, Logan, and Brisbane Bayside. The intent is to eventually enable all Aboriginal and Torres Strait Islander families across the urban Southeast Queensland region to have the BiOC model available as an option for their birthing care.

Trial website

Trial related presentations / publications

Public notes

Ethics was submitted for the Qualitative component on 13 December 2023 and the approval was received on 5 March 2024. Participant data was only collected for the Qualitative component after ethics approval was granted.
Ethics was submitted for the Quantitative component (including the economic evaluation component) on 28 August 2025 and the approval was obtained on 19 September 2025. Cumulative participant data is planned to be obtained by the research team for the Quantitative component after 31 December 2026.
For the quantitative portion in particular, ethics was not obtained prior to the start of data collection (1 July 2022) because of administrative reasons. The study team was allowed to obtain ethics approval mid-recruitment because:
- All the perinatal and birth clinical data collection is undertaken at birth by hospital midwives and not by BiOC LEWIS research team members, and this clinical data will be accessed for research purpose by the research team only after 31 December 2026 through data linkage with the QLD Perinatal data collection (QPDC).
- The BiOC LEWIS research team also obtained a waiver of consent though a Public Health Act (PHA) application for all data collected prior to February 2025.
- The PHA application also allowed the research team to gain data custodian approvals to access routinely collected perinatal data from the Statistical Service Branch (SSB) of Queensland. IUIH signed the PHA as a data custodian of their web-based e-Health platform (MMeX) to provide mum-baby identifiers and post-natal follow-up data to be linked with QPDC.
- MMeX data is recorded by BiOC staff during antenatal and postnatal period and this data will not be available to the research team until after 31/12/2026.

Contacts

Principal investigator

Name

Mr Adrian Carson

Address

Institute for Urban Indigenous Health - 22 Cox Road, Windsor, Queensland 4030

Country

Australia

Phone

+61 410 089 402

Fax

[email protected]

Contact person for public queries

Name

Rupesh Gautam

Address

Institute for Urban Indigenous Health - 22 Cox Road, Windsor, Queensland 4030

Country

Australia

Phone

+61 456256742

Fax

[email protected]

Contact person for scientific queries

Name

Adrian Carson

Address

Institute for Urban Indigenous Health - 22 Cox Road, Windsor, Queensland 4030

Country

Australia

Phone

+61 410 089 402

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: The data from this study will not be made available due to Indigenous data sovereignty principles, which require that data remain under the custodianship and governance of the communities from whom they originate.

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.

Trial Review

Documents added manually

Documents added automatically