ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001365257

Ethics application status

Approved

Date submitted

13/07/2018

Date registered

14/08/2018

Date last updated

17/05/2022

Date data sharing statement initially provided

17/05/2022

Date results provided

17/05/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Indigenous Birthing in an Urban Setting (IBUS) Study: Improving maternal infant health
care for Aboriginal and Torres Strait Islander women and infants

Scientific title

The Indigenous Birthing in an Urban Setting (IBUS) Study: Improving maternal infant health
care for Aboriginal and Torres Strait Islander women and infants through a multi-agency partnership

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

IBUS

Linked study record

ACTRN12615001278527 is a sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study:
“Stop Smoking in its Tracks”: a single arm intervention study of a smoking cessation program for women receiving maternity care through the Birthing in Our Community program. A sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study

Health condition

Health condition(s) or problem(s) studied:

infant health

preterm birth

Condition category

Condition code

Public Health

Health service research

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

Breast feeding

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

Complications of newborn

Reproductive Health and Childbirth

Contraception

Reproductive Health and Childbirth

Normal pregnancy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Birthing in Our Community is a complex intervention designed to improve maternal and infant health outcomes for Indigenous families in an urban setting. Launched in 2013, Birthing in Our Community was developed in partnership between the Mater Mothers Hospital, and two local Aboriginal community-controlled health organisations: the Institute for Urban Indigenous Health and the Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd.

Key components of the intervention include:
• Indigenous governance (operating through a Steering Committee) functioning in accordance with Terms of Reference and underpinned by a MOU
• A community-based Midwifery Group Practice (MGP), which provides continuity of carer to enrolled women throughout pregnancy, birth and up to six weeks postnatally. Care is provided according to hospital guidelines and protocols in the home, at community venues where regular cultural and education days are held, or in the hospital
• 24/7 access to caseload midwife who works in MGP on annualised salary with each woman allocated a primary midwife. Midwife support during birthing is likely to be by a known midwife
• Location for birth is the Birth Suite (no homebirth or Birth Centre services provided)
• Indigenous Maternal Infant Health/ Family Support Workers and Indigenous student midwives work with the caseload midwives to provide culturally tailored care
• Referral to Indigenous community support agencies as required; All women are offered a formal handover to child health services with other referrals as required (e.g. paediatric, allied health)
• Clinical / cultural supervision for staff
• Indigenous Liaison Officers are based in the hospital to strengthen culturally responsive care and support
• Access to medical staff, allied health professionals, social workers, child safety officers and other professionals as required (e.g. Diabetic educator)
• Discharge letter to referral doctor and referrals to community support agencies as required
Referred to as Group 1, data collected Jul 2013 to Dec 2019

Intervention code [1]

Treatment: Other

Comparator / control treatment

Ngarrama Indigenous Maternity Service (Active Concurrent Control Group 4 - Jul 2013 to Dec 2019) at RBWH
• A hospital-based Midwifery Group Practice (MGP), which provides continuity of carer to enrolled women throughout pregnancy, birth and up to six weeks postnatally. Care is provided according to hospital guidelines and protocols, regardless of setting (women’s homes, community venues or hospital)
• 24/7 access to MGP midwives who work in a small team and are on annualised salary with each woman allocated a primary midwife. Midwife support during birthing is likely to be by a known midwife.
• Location for birth may be in the Birth Suite or the co-located Birth Centre (eligibility criteria apply);
• Access to Cultural Capability Officers of the Metro North Aboriginal and Torres Strait Islander Health Unit who provide additional cultural guidance and support.

Standard Care (Historical Control Group 2 - Jan 2009 to Jun 2013 & Active Concurrent Control Group 5 - Jul 2013 to Dec 2019, at both hospitals )
• Antenatal care may be received from community based general practitioner, hospital based midwives or doctors who rotate throughout the service on rosters. Midwife support during birthing is likely to be by a person the woman has never met. Postnatal care or phone call from a rostered community midwife might take place if the woman meets the criteria for early discharge—before 48 h for vaginal birth and 72 h for caesarean section usually for up to less than 2 weeks
• Women can call the hospital birthing suite in an emergency
• Location for birth same as other groups for the hospitals
• Some aspects of the Intervention may be present but not all and there is no overarching Indigenous governance or clinical / cultural supervision for staff

Standard Care non-Indigenous babies and their mothers (Historical Control Group 3 - Jan 2009 to Jun 2013 & Active Concurrent Control Group 6 - Jul 2013 to Dec 2019, at both hospitals
• Antenatal care may be received from community based general practitioner, hospital based midwives or doctors who rotate throughout the service on rosters. Midwife support during birthing is likely to be by a person the woman has never met. Postnatal care or phone call from a rostered community midwife might take place if the woman meets the criteria for early discharge—before 48 h for vaginal birth and 72 h for caesarean section usually for up to less than 2 weeks
• Women can call the hospital birthing suite in an emergency
• Location for birth same as other groups for the hospitals
• Some aspects of the Intervention may be present for some women (e.g. MGP care)

Control group

Active

Outcomes

Primary outcome [1]

Proportion of women giving birth preterm (< 37 weeks gestation) - data derived from hospital records

Timepoint [1]

Birth

Primary outcome [2]

Proportion of women who attend five or more antenatal visits during pregnancy - data derived from hospital records

Timepoint [2]

Birth

Primary outcome [3]

The proportion of women smoking after 20 weeks gestation - data derived from hospital records

Timepoint [3]

Birth

Secondary outcome [1]

Gestation at first antenatal visit to a health provider, at booking into hospital (weeks, Mean, Median, Range, First trimester (Yes/No))- data derived from hospital records

Timepoint [1]

At booking

Secondary outcome [2]

Number of total antenatal visits (Mean, SD, Median, Range, <5 visits, 5 and more visits)- data derived from hospital records

Timepoint [2]

Birth

Secondary outcome [3]

Women having attended antenatal education sessions (Yes/No)-data derived from survey designed for this study

Timepoint [3]

8 weeks postnatal

Secondary outcome [4]

Smoking status at booking (Yes/No), during the first 20 weeks (Yes/No), and after the first 20 weeks (Yes/No), at discharge (Yes/No) and six months postnatal (Yes/No), and number of cigarettes intake each day if smokers (Mean, SD)- data derived from hospital records and survey designed for this study

Timepoint [4]

Birth, 8 weeks postnatal and 6 months postnatal

Secondary outcome [5]

Pregnancy complications: Gestational diabetes (Yes/No), Pregnancy induced hypertension (Yes/No), Antenatal haemorrhage (Yes/No) - data derived from hospital records

Timepoint [5]

Birth

Secondary outcome [6]

Non-pharmacological analgesia (Yes/No)- data derived from hospital records

Timepoint [6]

Birth

Secondary outcome [7]

Pharmacological analgesia in labour (Epidural/spinal analgesia, Narcotic analgesia, Nitrous oxide gas) -data derived from hospital records

Timepoint [7]

Birth

Secondary outcome [8]

Onset of labour (Induced, No labour, Spontaneous) - data derived from hospital records

Timepoint [8]

Birth

Secondary outcome [9]

Mode of birth (Non-instrumental vaginal birth, Instrumental vaginal birth, Elective Caesarean section, Emergency Caesarean section)- data derived from hospital records

Timepoint [9]

Birth

Secondary outcome [10]

Management of third stage of labour (Active, Physiological)- data derived from hospital records

Timepoint [10]

On completion of third stage of labour

Secondary outcome [11]

Postpartum haemorrhage (<500ml, 500-999ml, 1000-1499ml, 1500ml and more or with blood transfusion) -data derived from hospital records

Timepoint [11]

During labour or prior to hospital discharge

Secondary outcome [12]

Perineal trauma status (Intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear) - data derived from hospital records

Timepoint [12]

Birth

Secondary outcome [13]

Episiotomy (Yes/No)- data derived from hospital records

Timepoint [13]

Birth

Secondary outcome [14]

Women having a known caregiver for labour and birth (Yes/No)- data derived from hospital records and survey designed for this study

Timepoint [14]

Birth and 8 weeks postnatal

Secondary outcome [15]

Birth weight (grams, Mean, SD, <2500g, 2500g or more)-data derived from hospital records

Timepoint [15]

Birth

Secondary outcome [16]

Apgar score at 5 minutes (<7, 7 or above) -data derived from hospital records

Timepoint [16]

Five minutes after birth

Secondary outcome [17]

Admission to a separate neonatal nursery (Yes/No)- data derived from hospital records

Timepoint [17]

At discharge from hospital following birth

Secondary outcome [18]

Perinatal outcomes (Liveborn survived, Liveborn neonatal death prior discharge from hospital, stillbirth) -data derived from hospital records

Timepoint [18]

At discharge from hospital following birth

Secondary outcome [19]

Cause of perinatal deaths - data derived from hospital records

Timepoint [19]

At discharge from hospital following birth

Secondary outcome [20]

Antenatal exclusive breastfeeding intention (Yes/No)- data derived from hospital records

Timepoint [20]

Prior to birth

Secondary outcome [21]

Women exclusively feeding at breast at discharge from hospital following birth (Yes/No; also Primary outcome), at 2 months postnatal (Yes/No) and 6 months postnatal (Yes/No)- data derived from hospital records and survey designed for this study

Timepoint [21]

Birth, 2 and 6 months postnatal

Secondary outcome [22]

Infant readmission to hospital up to 6 months of age (Yes/No)- data derive from hospital records and survey designed for this study

Timepoint [22]

6 months postpartum

Secondary outcome [23]

Length of stay in hospital for mothers and infants following birth (Mean, Median, Range) -data derived from hospital records

Timepoint [23]

At discharge from hospital following birth

Secondary outcome [24]

Cost of care per mother/infant pair during pregnancy, birth, and postnatal until mother 6 weeks postpartum and baby 28 days after birth (DRG and ICD code for hospital admissions) -data derived from hospital records

Timepoint [24]

6 weeks postnatal

Secondary outcome [25]

Negative life events scale - full extended version

Timepoint [25]

Booking, 6 months postnatal

Secondary outcome [26]

Modified Kessler Psychological Distress Scale (K5) score

Timepoint [26]

Booking, 36 weeks gestation, 2 & 6 months postnatal

Secondary outcome [27]

Edinburgh Postnatal Depression Scale score

Timepoint [27]

Booking, 6 months postnatal

Secondary outcome [28]

Ages and Stages Questionnaire score

Timepoint [28]

2 and 6 months postnatal

Secondary outcome [29]

Bayley III Cognitive, Language and Motor Skills

Timepoint [29]

six months postnatal

Secondary outcome [30]

Mother readmission to hospital up to 6 months postpartum (Yes/No)- data derive from hospital records and survey designed for this study

Timepoint [30]

6 months postpartum

Eligibility

Key inclusion criteria

Women’s surveys, Tell My Story and Infant Assessments: Women are eligible to participate if they:
• Identify as Aboriginal and/or Torres Strait Islander, or identify their baby as Aboriginal and/or Torres Strait Islander person;
• Receive their maternity care through the Birthing in Our Community Program and are planning to birth at the MMH (Group 1); receive their maternity care through the Ngarrama Indigenous Maternity Service and are planning to birth at the RBWH (Group 4); receive standard maternity care and birth at the MMH or RBWH (Groups 2 & 5) and
• Consent to participate.

Infants are eligible if:
• They are Aboriginal and Torres Strait Islander babies and their mothers received care through either of these programs and were recruited to the study.

Staff are eligible to participate in the staff surveys, interviews and focus groups if they have been involved in the planning and/or provision of maternity care services for Aboriginal and Torres Strait Islander families in South East Queensland during the study period; and consent to participate.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Women are not eligible to participate if they:
• Have been transferred into the RBWH or the MMH from out of area for high-level specialist services or received no antenatal care.

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)

There is no allocation concealment, both women and care providers are aware of their model of care.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Some participants receive parallel assignment (self- selected or allocated depending on available spaces but there is also historical control groups.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Quantitative analyses will compare the difference in clinical outcomes between Birthing in Our Community (intervention), the Ngarrama Service (concurrent control), standard care (historical and concurrent control), and also non-Indigenous women and babies (historical and concurrent control) at MMH and RBWH.

This study has been powered to detect changes in clinical outcomes. During the 3.5 year recruitment period, we will aim to access routinely collected data for approximately 420 women at MMH, and 350 from RBWH (based on an estimated 20% attrition rate). The change in outcomes has been estimated based on changes seen in the Townsville Mums and Bubs program that reported a reduction in preterm birth.

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) that could affect outcome measures. Dependent on data type, analysis will be undertaken using an independent samples t-test, Mann-Whitney U test or chi-squared test. Outcome measures will be presented using relative risks with 95% confidence intervals. Multivariate logistic, linear regression models and propensity score matching will be used to adjust for confounders. Longitudinal outcomes (e.g. breastfeeding) will be analysed with generalized estimating equations to account for the correlation between observations repeated in the same person. To understand the mechanism or process that underlies the effect of model of care on outcomes, mediation analysis will be conducted to identify if and to what extent the other variables explains the relationship. All withdrawals, losses to follow-up, and deaths will be reported. Analysis will be performed with SPSS Version 22.0/Stata 14.0 and statistical significance will be at the 0.05 level.

The cost-effectiveness analysis will be conducted to examine the direct costs, from a societal perspective, to women and their families, maternity and child health care services and other community services in relation to pregnancy and birth. We will compare the mean costs per mother/infant pair between Birthing in Our Community (Group 1) and the Ngarrama Service (Group 4) to standard care group (Group 2 and 5) up to six weeks postpartum. Costs will be calculated for both mother and baby to include: women and family’s out-of-pocket expenses related to clinic appointments, outpatients (ultrasound, pathology, etc.) and prescribed medicines, and hospitalisation costs. Data will be collected through routinely collected information as well as questions embedded in the 36 week antenatal and two month postnatal surveys. Average costs for each mother and infant for the duration of the maternity episode (i.e. from when she first confirmed her pregnancy to six weeks postnatal) will be calculated and compared to determine the cost effectiveness of a model of care.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

16/10/2015

Date of last participant enrolment

Anticipated

30/04/2019

Actual

18/01/2019

Date of last data collection

Anticipated

31/12/2019

Actual

31/12/2019

Sample size

Target

770

Accrual to date

Final

618

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4101 - South Brisbane

Recruitment postcode(s) [2]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke Street, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Mater Mothers Hospital

Address [2]

Raymond Tce, South Brisbane, Qld 4101

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Institute for Urban Indigenous Health

Address [3]

22 Cox Rd, Windsor, Qld 4030

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

Aboriginal and Torres Strait Islander Community Health Service Brisbane Limited

Address [4]

55 Annerley Rd, Woolloongabba, Qld 4102

Country [4]

Australia

Funding source category [5]

Government body

Name [5]

Queensland Health

Address [5]

33 Charlotte Street, Brisbane, Qld 4000

Country [5]

Australia

Primary sponsor type

Individual

Name

Prof Sue Kildea

Address

Mater Research
Level 1, Aubigny Place, South Brisbane, Qld 4101

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof Sue Kruske

Address [1]

Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

A/Prof Megan Passey

Address [2]

University Centre for Rural Health, University of Sydney
61 Uralba St, Lismore, NSW 2480

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Prof Sally Tracy

Address [3]

The University of Sydney
88 Mallett Street - Building A
Camperdown NSW 2050

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Dr Anton Clifford

Address [4]

Mater Research
Aubigny Place, Raymond Tce, Qld 4101

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

A/Prof Carmel Nelson

Address [5]

Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Dr Yvette Roe

Address [6]

Mater Research
Aubigny Place, Raymond Tce, South Brisbane, Qld 4101

Country [6]

Australia

Secondary sponsor category [7]

Individual

Name [7]

Prof Roianne West

Address [7]

First Peoples Health Unit, Griffith University
Parklands Dr, Southport QLD 4215

Country [7]

Australia

Other collaborator category [1]

Individual

Name [1]

Renee Blackman

Address [1]

Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd
55 Annerley Rd, Woolloongabba, Qld 4102

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Jody Currie

Address [2]

Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd
55 Annerley Rd, Woolloongabba, Qld 4102

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Adrian Carson

Address [3]

Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Machellee Kosiak

Address [4]

Australian Catholic University
1100 Nudgee Rd, Banyo QLD 4014

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Shannon Watego

Address [5]

Mater Misericordiae Limited
Raymond Tce, South Brisbane, Qld 4101

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Kay Wilson

Address [6]

Mater Misericordiae Limited
Raymond Tce, South Brisbane, Qld 4101

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Prof Joan Webster

Address [7]

Nursing and Midwifery Research Centre, Level 2, Bld 34, RBWH, Butterfield Street, Herston, Qld 4029

Country [7]

Australia

Other collaborator category [8]

Individual

Name [8]

Cameron Hurst

Address [8]

Queensland Institute of Medical Research Berghofer
300 Herston Rd, Brisbane City QLD 4006

Country [8]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Limited Human Research Ethics Committee

Ethics committee address [1]

Aubigny Place, Raymond Tce, South Brisbane, Qld 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/03/2015

Approval date [1]

15/04/2015

Ethics approval number [1]

HREC/15/MHS/24

Summary

Brief summary

With persisting maternal and infant health disparities, new models of maternity care are needed to meet the needs of Aboriginal and Torres Strait Islander people in Australia. To date, there is limited evidence of successful and sustainable programs. Birthing on Country is an emerging evidence-based and community-led model of maternity care; the principles underpin a newly established service model: Birthing in Our Community. The Indigenous Birthing in an Urban Setting study is a mixed-methods  prospective birth cohort study comparing different models of care for women having Aboriginal and Torres Strait Islander babies at two major maternity hospitals in urban South East Queensland. It includes women’s surveys (booking-in to model at~20 weeks gestation, 36 weeks gestation, two and six months postnatal) and infant assessments (two and six months postnatal), clinical outcomes and cost comparison, and qualitative interviews with women and staff. This study aims to evaluate the feasibility, acceptability, sustainability, effectiveness and efficiency of a Birthing on Country model of care for Aboriginal and Torres Strait Islander families in an urban setting. If successful, findings will inform implementation of the model with similar communities.

Trial website

https://www.birthingoncountry.com/ibus

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sue Kildea

Address

CDU, 410 Ann St, East Tower Level 11, Brisbane Q 4000

Country

Australia

Phone

+61 7 3163 6388

Fax

Email

[email protected]

Contact person for public queries

Name

Sue Kildea

Address

CDU, 410 Ann St, East Tower Level 11, Brisbane City QLD 4000

Country

Australia

Phone

+61 7 3163 6388

Fax

Email

[email protected]

Contact person for scientific queries

Name

Sue Kildea

Address

CDU, 410 Ann St, East Tower, Brisbane QLD 4000

Country

Australia

Phone

+61 7 3163 6388

Fax

Email

[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 quantitative data

When will data be available (start and end dates)?

2022-2025

Available to whom?

Case-by-case basis at the discretion of Chief Investigator and Steering Committee

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]) on reasonable request pending
approval by the Birthing in Our Community Steering Committee to ensure
Indigenous data sovereignty guidelines are adhered to.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16096	Study protocol	Hickey, S., Roe, Y., Gao, Y. et al. The Indigenous Birthing in an Urban Setting study: the IBUS study. BMC Pregnancy Childbirth 18, 431 (2018). https://doi.org/10.1186/s12884-018-2067-8	https://doi.org/10.1186/s12884-018-2067-8
16097	Statistical analysis plan			[email protected]
16098	Informed consent form			[email protected]
16099	Ethical approval	HREC/15/MHS/24

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
Dimensions AI	The Indigenous Birthing in an Urban Setting study: the IBUS study	2018	https://doi.org/10.1186/s12884-018-2067-8

N.B. These documents automatically identified may not have been verified by the study sponsor.