ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000874910

Ethics application status

Approved

Date submitted

9/06/2020

Date registered

2/09/2020

Date last updated

2/09/2020

Date data sharing statement initially provided

2/09/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Developing and evaluating a Birthing On Country service to determine the effect on maternal and infant health outcomes for First Nations Australians

Scientific title

Building on Our Strengths (BOOSt): Developing and Evaluating a Birthing On Country Service for First Nations Australians, with integrated Community Hub and Birth Centre, to determine effects on maternal and infant health outcomes

Secondary ID [1]

NHMRC: GNT1135125

Universal Trial Number (UTN)

Trial acronym

BOOSt (Building on Our Strengths)

Linked study record

Health condition

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

maternal health

preterm birth

infant health

pregnancy

perinatal depression

perinatal anxiety

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

Childbirth and postnatal care

Public Health

Health service research

Reproductive Health and Childbirth

Normal pregnancy

Reproductive Health and Childbirth

Breast feeding

Reproductive Health and Childbirth

Complications of newborn

Mental Health

Depression

Public Health

Health promotion/education

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A Birthing on Country Service is a complex intervention that includes:
(i) Aboriginal and/or Torres Strait Islander-led governance of the service (through Aboriginal Community Controlled Health Organisations - ACCHOs)
(ii) An Aboriginal and/or Torres Strait Islander workforce strategy with career pathways for staff e.g. cadetships to support Aboriginal and/or Torres Strait Islander midwifery education and positions for workers such as Aboriginal Family Support Workers to work side-by-side with midwives
(iii) Continuity of midwifery carer offering 24/7 care from a named midwife from first presentation in pregnancy until handover to child health services 6 weeks after birth. This care is organised as a midwifery group practice integrated with other health services. Midwife-participant contact will involve one-to-one visits conducted either in person, or via video conferencing (or a mixture of both, as required). As with standard care, telephone contact may also occur. These appointments may occur in any setting - primary care (e.g. clinic or community-based health/birth centre), hospital, or home, as they will occur throughout the pregnancy, birth and postpartum periods.
(iv) Care throughout the pregnancy to postpartum period in collaboration with the extended healthcare workforce based on need (e.g. obstetrician, pediatrician, psychologist). Care and collaboration needs will be assessed from first presentation until handover to child health services 6 weeks after birth and this is the period of assessment (however, care will not be terminated at the end point, if it is needed on an ongoing basis, and may have been accessed prior to pregnancy). Appointments may occur in a community-based, primary care or secondary (hospital) setting. As with standard care, these additional services will be offered when deemed necessary by the lead maternity carer, and may be more accessible than those offered through hospital-only settings, but similarly women can decide whether the care offered may meet their own specific needs, and care is equally available to intervention and control groups.
(v) A focus on strengthening family capacity and cultural connection to improve health and well-being. A variety of delivery mechanisms will be utilised e.g. one-to-one and/or group sessions/workshops, and may include diverse settings e.g. counselling/workshops in community-based settings, home visits, and regular cultural days and camps in the bush. The period of assessment is from first presentation in pregnancy until handover to child health at 6 weeks postpartum, however, services may be accessed beyond that period. Additional services will be offered if deemed potentially helpful, and may be more accessible than those offered through hospital-only settings, but similarly women can decide whether the services/care offered may meet their own specific needs. This may include referral to counselling, case management services, and/or involvement of other community support agencies as required. Model components are administered by ACCHO partners.
(vi) Care provided outside of the hospital, for example from a community hub, and if feasible, a free-standing birth centre for women with uncomplicated pregnancies, and for women with complex pregnancies - birthing services will be provided in the local or tertiary hospital. The care model commences from the first day of pregnancy until handover to child health services 6 weeks after birth. The intervention model of maternity care is due to commence in 2021, we plan to study it from the launch (aiming for 36 months duration - including a possible extension of existing period).
Care is woman centred, individualised and incorporates traditional practices if women desire it; it recognises the connection between Aboriginal and/or Torres Strait Islander people with land and country; it utilises a holistic view of health, recognising and addressing where possible the social determinants of health; values both Aboriginal and/or Torres Strait Islander and non-Indigenous ways of knowing, learning and risk assessment; and provides a culturally competent service through various activities including cultural supervision.
As indicated, the intervention involves a redesign of maternity care and we are working with communities and organisations, capturing both pre- and post-intervention data. Adherence to model fidelity will be assessed concurrently through the embedded process evaluation component.

Intervention code [1]

Treatment: Other

Intervention code [2]

Early detection / Screening

Intervention code [3]

Prevention

Comparator / control treatment

Historical control where women received standard maternity care. Seven years of historical control data will be collected from hospital medical/maternity records and primary care records of pregnancy, birth and postpartum covering the period, at best estimate, from July 2013 to December 2020.

Control group

Historical

Outcomes

Primary outcome [1]

First antenatal visit in the first trimester (<14 weeks) (yes/no) - data will be derived from medical/maternity records.
*An antenatal visit is defined as "a planned visit between a pregnant woman and a midwife or doctor to assess and improve the wellbeing of the mother and baby throughout pregnancy. It does not include visits where the sole purpose is to confirm the pregnancy (AIHW, 2018, Australia's Mothers & Babies [brief], p5)

Timepoint [1]

The first antenatal visit date is entered/ascertained from the appointment date entered into maternity records based on a clearly defined first visit content/criteria (it could be at any stage of the pregnancy) - data collected from medical/maternity records following birth.

Primary outcome [2]

Preterm birth (<37 weeks’ gestation) - data derived from medical/maternity records

Timepoint [2]

At birth

Primary outcome [3]

Healthy baby (live born, singleton, >=37 weeks gestation, 2,500-4,499g birthweight, Apgar score at five minutes >=7 - data derived from medical/maternity records - this is a composite outcome

Timepoint [3]

At birth

Secondary outcome [1]

Women's cultural safety views and experiences - data derived from a survey designed for this study and qualitative data collected via audio recorded, one-to-one yarning (a type of narrative interviewing), unstructured interviews, and yarning circles (a type of focus group discussion). Experiences will be collected from women in both intervention and standard/non-intervention care groups. Survey questionnaires include e.g. questions on women's experiences of culturally safe care and/or non-culturally safe care, and the importance and availability of various aspects of care for it to be considered culturally safe.

Timepoint [1]

Three questionnaires will be administered at approximately 28-36 weeks of pregnancy, 2 & 6 months postpartum. The main qualitative data collection will occur between approximately 2 & 6 months postpartum. The time period under consideration for the intervention is from the first day of pregnancy until handover to child health services at 6 weeks postpartum, however the study is longitudinal following mothers and babies until 6 months.

Secondary outcome [2]

Women's experiences of (dis)respect - data derived from a survey designed for this study and qualitative data collected via audio recorded, one-to-one yarning (a type of narrative interviewing), unstructured interviews, and yarning circles (a type of focus group discussion). Experiences will be collected from women in both intervention and standard/non-intervention care groups. Questionnaires include e.g. questions on women's experiences of inter-personal interactions with healthcare personnel, and their feelings in response.

Timepoint [2]

Three questionnaires will be administered at approximately 28-36 weeks of pregnancy, 2 & 6 months postpartum. Besides some open-ended questions in the questionnaires, the main qualitative data collection will occur between approximately 2 & 6 months postpartum. The time period under consideration for the intervention is from the first day of pregnancy until handover to child health services at 6 weeks postpartum however the study is longitudinal following mothers and babies until 6 months.

Secondary outcome [3]

Women's experiences of discrimination/racism - data derived from a survey designed for this study and qualitative data collected via audio recorded, one-to-one yarning (a type of narrative interviewing), unstructured interviews, and yarning circles (a type of focus group discussion). Experiences will be collected from women in both intervention and standard/non-intervention care groups. Questionnaires include e.g. questions on women's experiences while attending healthcare appointments, as well as recent or ever experienced racism in various institutional contexts.

Timepoint [3]

Secondary outcome [4]

Women's cultural connection and identity - data derived from a survey designed for this study and qualitative data collected via audio recorded, one-to-one yarning (a type of narrative interviewing), unstructured interviews, and yarning circles (a type of focus group discussion). Experiences will be collected from women in both intervention and standard/non-intervention care groups. Questionnaires include e.g. questions on women's connection with community and Country.

Timepoint [4]

Secondary outcome [5]

Women's feelings of control during labour and birth - data derived from a survey designed for this study and qualitative data collected via audio recorded, one-to-one yarning (a type of narrative interviewing), unstructured interviews, and yarning circles (a type of focus group discussion). Experiences will be collected from women in both intervention and standard/non-intervention care groups. One questionnaire (2 months postpartum) includes a specific question on the level of control women felt where they are asked to rate on a 0-10 scale.

Timepoint [5]

Three questionnaires will be administered at approximately 28-36 weeks of pregnancy, 2 & 6 months postpartum. Besides some open-ended questions in the questionnaires, the main qualitative data collection will occur between approximately 2 & 6 months postpartum. The time period under consideration is from the first day of pregnancy until handover to child health services at 6 weeks postpartum.

Secondary outcome [6]

Total number of antenatal visits (0-4; 5 or more) - data derived from medical/maternity records (this is a PRIMARY OUTCOME)

Timepoint [6]

The time period under consideration is from the first day of pregnancy until birth. This may or may not be related to care in the intervention model (i.e. in standard care, or a mixture of both).

Secondary outcome [7]

Smoking status at first antenatal visit (yes/no), during the first 20 weeks (yes/no), and after the first 20 weeks (yes/no) - data derived from medical records and survey designed for this study

Timepoint [7]

The outcome will be assessed at several time points. At the first antenatal visit (this can occur at any time during pregnancy) (fixed timepoint), at/or before 20 weeks gestation (fixed timepoint at 20 weeks), at/and including 20+1 weeks gestation until birth (fixed timepoint = at birth). Additionally, questionnaires will be administered at approximately 28-36 weeks of pregnancy, and at 2 months postpartum (these assess self reported smoking status and smoke exposure at home).

Secondary outcome [8]

The Edinburgh Postnatal Depression Scale (EPDS) score - data derived from medical/maternity records and questionnaires designed for this study

Timepoint [8]

It is recommended the EPDS score is assessed at the first antenatal visit during pregnancy, but could also be assessed at other timepoint(s) as clinically indicated. It is documented in the medical/maternity records. The EPDS score will also be collected via questionnaires administered at approximately 2 & 6 months postpartum.

Secondary outcome [9]

Negative Life Events Scale (NLES) (full extended version) score – data derived from questionnaires designed for this study

Timepoint [9]

The NLES score will be collected via questionnaires administered at approximately 28-36 weeks of pregnancy, and at approximately 6 months postpartum.

Secondary outcome [10]

The modified Kessler psychological distress scale (K5) score – data derived from the scale that is embedded in questionnaires designed for this study

Timepoint [10]

The K5 score will be collected via questionnaires administered at approximately 28-36 weeks of pregnancy, and at approximately 2 and 6 months postpartum.

Secondary outcome [11]

Experienced continuity of care measured with 3 subscale scores of the Nijmegen Continuity Questionnaire (NCQ) pregnancy adaptation (1 personal continuity/care provider knows me, 2 personal continuity/care provider shows commitment, 3 team continuity) - data derived from the NCQ and additional questions embedded in questionnaires designed for this study.

Timepoint [11]

Questionnaire administered at approximately 2 months postpartum

Secondary outcome [12]

Pharmacological analgesia in labour (regional analgesia [epidural/spinal], narcotic analgesia, nitrous oxide gas) - data derived from medical records

Timepoint [12]

Birth

Secondary outcome [13]

Onset of labour (induced, no labour, spontaneous) - data derived from medical records

Timepoint [13]

Birth

Secondary outcome [14]

Augmentation of labour with artificial oxytocin - data derived from medical records

Timepoint [14]

Birth

Secondary outcome [15]

Place of birth (e.g. home, birth centre, hospital etc) - data derived from medical records

Timepoint [15]

Birth

Secondary outcome [16]

Mode of birth (non-instrumental vaginal birth, instrumental vaginal birth, caesarean section) - data derived from medical records

Timepoint [16]

Birth

Secondary outcome [17]

Water birth (yes/no) - data derived from medical records

Timepoint [17]

Birth

Secondary outcome [18]

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

Timepoint [18]

Birth

Secondary outcome [19]

Episiotomy (yes/no) - data derived from medical records

Timepoint [19]

Birth

Secondary outcome [20]

Management of third stage labour (active, physiological) - data derived from medical records

Timepoint [20]

Birth

Secondary outcome [21]

Postpartum haemorrhage (< 500; 500–999; 1000- 1499; 1500 ml and / or with blood transfusion - data derived from medical records

Timepoint [21]

At discharge, and up to 6 weeks postpartum

Secondary outcome [22]

Low birth weight (< 2500 g, 2500 g or more) - data derived from medical records

Timepoint [22]

Birth

Secondary outcome [23]

Birth weight (grams, mean, sd) - data derived from medical records

Timepoint [23]

Birth

Secondary outcome [24]

Apgar score 5 min (<7, 7 or above) - data derived from medical records

Timepoint [24]

Five minutes post-birth

Secondary outcome [25]

Admission to a separate neonatal nursery (yes/no) - data derived from medical records

Timepoint [25]

At discharge

Secondary outcome [26]

Breastfeeding status at two and six months postpatrum (exclusive, mixed, formula only, other) - data derived from survey designed for this study

Timepoint [26]

Questionnaires will be administered at approximately 2 & 6 months postpartum.

Secondary outcome [27]

Mother admission to hospital up to six weeks postpartum (yes/no) - data derived from medical records

Timepoint [27]

Birth up to 6 weeks

Secondary outcome [28]

Infant admission to hospital up to 28 days of age (yes/no) - data derived from medical records

Timepoint [28]

Birth up to 28 days

Secondary outcome [29]

The following secondary outcomes will be assessed separately: Length of facility stay for mothers and infants following birth (mean, median, range) - data derived from medical/maternity records

Timepoint [29]

At discharge

Secondary outcome [30]

The feasibility and acceptability of an established Birth Centre will be assessed by the proportion of eligible women in the intervention model of care, who start labour in the birth centre - data derived from medical/maternity records

Timepoint [30]

Birth

Secondary outcome [31]

The proportion of women who transferred from the birth centre/model of care at any time and for any reason - data derived from medical/maternity records

Timepoint [31]

At discharge

Secondary outcome [32]

Mean cost per mother/baby pair - data derived from medical DRG codes and facility finance data

Timepoint [32]

Pregnancy, birth, and up to 6 weeks postpartum

Secondary outcome [33]

Normal birth (>=37 weeks, vertex presentation, spontaneous onset of labour, no regional analgesia, spontaneous vaginal birth, no episiotomy) (this is a PRIMARY outcome) - data derived from medical/maternity records

Timepoint [33]

Birth

Secondary outcome [34]

Women who had a known midwife in labour and/or birth (yes/no) - data derived from survey designed for this study

Timepoint [34]

Birth

Secondary outcome [35]

Birthing and maternity care experiences - data derived from survey designed for this study

Timepoint [35]

Three questionnaires will be administered at approximately 28-36 weeks of pregnancy, 2 & 6 months postpartum. Besides some open-ended questions in the questionnaires, the main qualitative data collection will occur between approximately 2 & 6 months postpartum. The time period under consideration for the intervention is from the first day of pregnancy until handover to child health services at 6 weeks postpartum, however the study is longitudinal following mothers and babies until 6 months.

Secondary outcome [36]

Maternal parenting self-efficacy - data derived from survey designed for this study

Timepoint [36]

One questionnaire administered at approximately 2 months postpartum.

Secondary outcome [37]

Exclusive breast feeding at discharge (yes/no) - data derived from medical/maternity records and survey designed for this study - (this is a PRIMARY outcome).

Timepoint [37]

At facility discharge, and via a questionnaire administered at approximately 2 months postpartum.

Eligibility

Key inclusion criteria

Pregnant women 14 years and over booked to give birth at the hospital or birth centre at the study sites.

Minimum age

14 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Women not able or not willling to give informed consent

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)

none

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

self nominated (for care model participation, and survey enrolment - clinical data collected for this group and also non-enrolled controls) or historical control group (clinical data only).

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Multivariate logistic regression models, linear regression models, propensity score matching and multilevel modelling

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

7/09/2020

Actual

Date of last participant enrolment

Anticipated

30/11/2022

Actual

Date of last data collection

Anticipated

30/06/2023

Actual

Sample size

Target

1861

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

Shoalhaven Hospital - Nowra

Recruitment postcode(s) [1]

2541 - Nowra

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Waminda - South Coast Women's Health and Welfare Aboriginal Corporation

Address [2]

122 Kinghorne Street
Nowra
NSW 2541

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Institute for Urban Indigenous Health (IUIH)

Address [3]

22 Cox Road, Windsor,
QLD 4030

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

Aboriginal & Torres Strait Islander Community Health Service Brisbane Limited

Address [4]

55 Annerley Road
Woolloongabba, QLD 4102

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Congress of Aboriginal & Torres Strait Islander Nurses & Midwives (CATSINaM)

Address [5]

Level 1/15 Lancaster Pl, Majura Park ACT 2609

Country [5]

Australia

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Rhodanthe Lipsett Indigenous Midwifery Charitable Fund

Address [6]

4-6 Park Ln, Caringbah NSW 2229

Country [6]

Australia

Funding source category [7]

Charities/Societies/Foundations

Name [7]

Australian College of Midwives (ACM)

Address [7]

222 City Walk, Canberra ACT 2601

Country [7]

Australia

Funding source category [8]

University

Name [8]

The University of Queensland (UQ)

Address [8]

The University of Queensland
St Lucia QLD 4072, Australia

Country [8]

Australia

Funding source category [9]

University

Name [9]

The University of Sydney (USyd)

Address [9]

Camperdown, NSW 2006

Country [9]

Australia

Primary sponsor type

Individual

Name

Sue Kildea

Address

Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Sally Tracy

Address [1]

The University of Sydney
Camperdown, NSW 2006

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Juanita Sherwood

Address [2]

The University of Sydney
Camperdown, NSW 2006

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Lesley Barclay

Address [3]

The University of Sydney
Camperdown, NSW 2006

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Sue Kruske

Address [4]

c/- Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Yvette Roe

Address [5]

Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Donna Hartz

Address [6]

Charles Darwin University (Sydney)
815 George St, Haymarket, NSW 2000

Country [6]

Australia

Secondary sponsor category [7]

Individual

Name [7]

Carmel Nelson

Address [7]

Institute for Urban Indigenous Health (IUIH)
22 Cox Road, Windsor,
QLD 4030

Country [7]

Australia

Secondary sponsor category [8]

Individual

Name [8]

Mark Tracy

Address [8]

The University of Sydney
Camperdown, NSW 2006

Country [8]

Australia

Other collaborator category [1]

Individual

Name [1]

Luke Williamson

Address [1]

Australian College of Midwives (ACM)
222 City Walk, Canberra ACT 2601

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Jody Currie

Address [2]

Aboriginal & Torres Strait Islander Community Health Service (ATSICHS) Brisbane
55 Annerley Road
Woolloongabba, QLD 4102

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Leona McGrath

Address [3]

Congress of Aboriginal & Torres Strait Islander Nurses and Midwives (CATSINaM)
Level 1/15 Lancaster Pl, Majura Park ACT 2609

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Faye Worner

Address [4]

Waminda South Coast Women's Health & Welfare Aboriginal Corportation
122 Kinghorne Street
Nowra, NSW 2541

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Adrian Carson

Address [5]

Institute for Urban Indigenous Health (IUIH)
22 Cox Road, Windsor,
QLD 4030

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Cherisse Buzzacott

Address [6]

Rhodanthe Lipsett Indigenous Midwifery Charitable Fund
4-6 Park Ln, Caringbah NSW 2229

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Aboriginal Health & Medical Research Committee (AH&MRC) of New South Wales (NSW)

Ethics committee address [1]

35 Harvey St, Little Bay NSW 2036

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/12/2018

Ethics approval number [1]

1448/18

Ethics committee name [2]

Mater Misericordiae Limited Human Research Ethics Committee

Ethics committee address [2]

Aubigny Place, Raymond Tce, South Brisbane, QLD 4101

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

29/06/2018

Approval date [2]

10/09/2018

Ethics approval number [2]

HREC/18/MHS/107

Ethics committee name [3]

Charles Darwin University HREC

Ethics committee address [3]

PO Box 40146, Casuarina, Northern Territory, Australia 0811

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

10/07/2019

Ethics approval number [3]

H19054

Ethics committee name [4]

University of Queensland HREC

Ethics committee address [4]

Cumbrae-Stewart Building #72
The University of Queensland
St Lucia QLD 4072, Australia

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

28/09/2018

Ethics approval number [4]

2018001973/HREC/18/MHS/107

Ethics committee name [5]

Illawarra Shoalhaven Local Health District (ISLHD) Health & Medical HREC/University of Wollongong

Ethics committee address [5]

Research Services Office
Level 1, Building 20
Northfields Avenue
Wollongong  NSW  2522

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

18/12/2018

Ethics approval number [5]

2018/472

Ethics committee name [6]

Waminda Research Committee

Ethics committee address [6]

122 Kinghorne Street,
Nowra, NSW 2541

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

09/10/2018

Ethics approval number [6]

none provided

Summary

Brief summary

The health and well-being gap between Australia's First Nations peoples and non-Indigenous population has not been closing satisfactorily. Evidence indicating the effectiveness of Birthing on Country services is building.

Building on Our Strengths (BOOSt) aims to develop, implement and evaluate a Birthing On Country service for First Nations Australians, with an integrated Community hub and birth centre.  The study is of important national and international significance.

A Birthing on Country Service is a complex intervention that reorients maternity services in terms of governance, workforce, continuity of midwifery carer, collaborative care, a focus on strengthening family capacity and cultural connection to improve health and well-being, a community hub, and if feasible, a free-standing birth centre for women with uncomplicated pregnancies, and for women with complex pregnancies - birthing services in the local or tertiary hospital.  Culturally safe care is another component and the model recognises the connection between Aboriginal and/or Torres Strait Islander peoples with land and country and a holistic view of health.

The BOOSt study will capture both pre- and post-intervention data, while embedding a full evaluation to investigate the processes of model development in context, and those around model implementation.  A variety of data sources will be utilised to ensure accuracy and completeness, and to capture psycho-social health and well-being outcomes and behaviors, as well as medical outcomes.

Trial website

https://www.birthingoncountry.com/boost
http://www.waminda.org.au/birthing-on-country

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Susan Kildea

Address

Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country

Australia

Phone

+61 7 3169 4262

Fax

[email protected]

Contact person for public queries

Name

Susan Kildea

Address

Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country

Australia

Phone

+61 7 3169 4262

Fax

[email protected]

Contact person for scientific queries

Name

Susan Kildea

Address

Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000

Country

Australia

Phone

+61 7 3169 4262

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To be decided in collaboration with partners

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

Source	Title	Year of Publication	DOI
Embase	Developing and evaluating Birthing on Country services for First Nations Australians: the Building On Our Strengths (BOOSt) prospective mixed methods birth cohort study protocol.	2023	https://dx.doi.org/10.1186/s12884-022-05277-8

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

Trial Review

Documents added manually

Documents added automatically