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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] 299850 0
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 315245 0
preterm birth 315246 0
infant health 315247 0
pregnancy 315248 0
perinatal depression 317550 0
perinatal anxiety 318116 0
Condition category
Condition code
Reproductive Health and Childbirth 313552 313552 0 0
Antenatal care
Reproductive Health and Childbirth 313553 313553 0 0
Childbirth and postnatal care
Public Health 313554 313554 0 0
Health service research
Reproductive Health and Childbirth 313555 313555 0 0
Normal pregnancy
Reproductive Health and Childbirth 315638 315638 0 0
Breast feeding
Reproductive Health and Childbirth 315639 315639 0 0
Complications of newborn
Mental Health 315640 315640 0 0
Depression
Public Health 315641 315641 0 0
Health promotion/education
Mental Health 316137 316137 0 0
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] 316110 0
Treatment: Other
Intervention code [2] 317991 0
Early detection / Screening
Intervention code [3] 317992 0
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] 322008 0
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] 322008 0
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] 322009 0
Preterm birth (<37 weeks’ gestation) - data derived from medical/maternity records
Timepoint [2] 322009 0
At birth
Primary outcome [3] 322010 0
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] 322010 0
At birth
Secondary outcome [1] 383115 0
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] 383115 0
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] 383118 0
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] 383118 0
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] 383126 0
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] 383126 0
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 [4] 383160 0
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] 383160 0
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 [5] 383161 0
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] 383161 0
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] 383163 0
Total number of antenatal visits (0-4; 5 or more) - data derived from medical/maternity records (this is a PRIMARY OUTCOME)
Timepoint [6] 383163 0
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] 383165 0
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] 383165 0
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] 383166 0
The Edinburgh Postnatal Depression Scale (EPDS) score - data derived from medical/maternity records and questionnaires designed for this study
Timepoint [8] 383166 0
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] 383167 0
Negative Life Events Scale (NLES) (full extended version) score – data derived from questionnaires designed for this study
Timepoint [9] 383167 0
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] 383168 0
The modified Kessler psychological distress scale (K5) score – data derived from the scale that is embedded in questionnaires designed for this study
Timepoint [10] 383168 0
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] 383169 0
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] 383169 0
Questionnaire administered at approximately 2 months postpartum
Secondary outcome [12] 383170 0
Pharmacological analgesia in labour (regional analgesia [epidural/spinal], narcotic analgesia, nitrous oxide gas) - data derived from medical records
Timepoint [12] 383170 0
Birth
Secondary outcome [13] 383171 0
Onset of labour (induced, no labour, spontaneous) - data derived from medical records
Timepoint [13] 383171 0
Birth
Secondary outcome [14] 383172 0
Augmentation of labour with artificial oxytocin - data derived from medical records
Timepoint [14] 383172 0
Birth
Secondary outcome [15] 383174 0
Place of birth (e.g. home, birth centre, hospital etc) - data derived from medical records
Timepoint [15] 383174 0
Birth
Secondary outcome [16] 383175 0
Mode of birth (non-instrumental vaginal birth, instrumental vaginal birth, caesarean section) - data derived from medical records
Timepoint [16] 383175 0
Birth
Secondary outcome [17] 383176 0
Water birth (yes/no) - data derived from medical records
Timepoint [17] 383176 0
Birth
Secondary outcome [18] 383177 0
Perineal status (intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear) - data derived from medical records
Timepoint [18] 383177 0
Birth
Secondary outcome [19] 383178 0
Episiotomy (yes/no) - data derived from medical records
Timepoint [19] 383178 0
Birth
Secondary outcome [20] 383179 0
Management of third stage labour (active, physiological) - data derived from medical records
Timepoint [20] 383179 0
Birth
Secondary outcome [21] 383180 0
Postpartum haemorrhage (< 500; 500–999; 1000- 1499; 1500 ml and / or with blood transfusion - data derived from medical records
Timepoint [21] 383180 0
At discharge, and up to 6 weeks postpartum
Secondary outcome [22] 383182 0
Low birth weight (< 2500 g, 2500 g or more) - data derived from medical records
Timepoint [22] 383182 0
Birth
Secondary outcome [23] 383183 0
Birth weight (grams, mean, sd) - data derived from medical records
Timepoint [23] 383183 0
Birth
Secondary outcome [24] 383184 0
Apgar score 5 min (<7, 7 or above) - data derived from medical records
Timepoint [24] 383184 0
Five minutes post-birth
Secondary outcome [25] 383185 0
Admission to a separate neonatal nursery (yes/no) - data derived from medical records
Timepoint [25] 383185 0
At discharge
Secondary outcome [26] 383188 0
Breastfeeding status at two and six months postpatrum (exclusive, mixed, formula only, other) - data derived from survey designed for this study
Timepoint [26] 383188 0
Questionnaires will be administered at approximately 2 & 6 months postpartum.
Secondary outcome [27] 383189 0
Mother admission to hospital up to six weeks postpartum (yes/no) - data derived from medical records
Timepoint [27] 383189 0
Birth up to 6 weeks
Secondary outcome [28] 383190 0
Infant admission to hospital up to 28 days of age (yes/no) - data derived from medical records
Timepoint [28] 383190 0
Birth up to 28 days
Secondary outcome [29] 383191 0
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] 383191 0
At discharge
Secondary outcome [30] 383192 0
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] 383192 0
Birth
Secondary outcome [31] 383194 0
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] 383194 0
At discharge
Secondary outcome [32] 383195 0
Mean cost per mother/baby pair - data derived from medical DRG codes and facility finance data
Timepoint [32] 383195 0
Pregnancy, birth, and up to 6 weeks postpartum
Secondary outcome [33] 383223 0
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] 383223 0
Birth
Secondary outcome [34] 383224 0
Women who had a known midwife in labour and/or birth (yes/no) - data derived from survey designed for this study
Timepoint [34] 383224 0
Birth
Secondary outcome [35] 383241 0
Birthing and maternity care experiences - data derived from survey designed for this study
Timepoint [35] 383241 0
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] 383652 0
Maternal parenting self-efficacy - data derived from survey designed for this study
Timepoint [36] 383652 0
One questionnaire administered at approximately 2 months postpartum.
Secondary outcome [37] 384450 0
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] 384450 0
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?
No
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] 16750 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 30361 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 304307 0
Government body
Name [1] 304307 0
NHMRC
Country [1] 304307 0
Australia
Funding source category [2] 304308 0
Commercial sector/Industry
Name [2] 304308 0
Waminda - South Coast Women's Health and Welfare Aboriginal Corporation
Country [2] 304308 0
Australia
Funding source category [3] 305776 0
Commercial sector/Industry
Name [3] 305776 0
Institute for Urban Indigenous Health (IUIH)
Country [3] 305776 0
Australia
Funding source category [4] 305777 0
Commercial sector/Industry
Name [4] 305777 0
Aboriginal & Torres Strait Islander Community Health Service Brisbane Limited
Country [4] 305777 0
Australia
Funding source category [5] 305778 0
Charities/Societies/Foundations
Name [5] 305778 0
Congress of Aboriginal & Torres Strait Islander Nurses & Midwives (CATSINaM)
Country [5] 305778 0
Australia
Funding source category [6] 305779 0
Charities/Societies/Foundations
Name [6] 305779 0
Rhodanthe Lipsett Indigenous Midwifery Charitable Fund
Country [6] 305779 0
Australia
Funding source category [7] 305780 0
Charities/Societies/Foundations
Name [7] 305780 0
Australian College of Midwives (ACM)
Country [7] 305780 0
Australia
Funding source category [8] 305781 0
University
Name [8] 305781 0
The University of Queensland (UQ)
Country [8] 305781 0
Australia
Funding source category [9] 305782 0
University
Name [9] 305782 0
The University of Sydney (USyd)
Country [9] 305782 0
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] 304553 0
Individual
Name [1] 304553 0
Sally Tracy
Address [1] 304553 0
The University of Sydney
Camperdown, NSW 2006
Country [1] 304553 0
Australia
Secondary sponsor category [2] 306214 0
Individual
Name [2] 306214 0
Juanita Sherwood
Address [2] 306214 0
The University of Sydney
Camperdown, NSW 2006
Country [2] 306214 0
Australia
Secondary sponsor category [3] 306215 0
Individual
Name [3] 306215 0
Lesley Barclay
Address [3] 306215 0
The University of Sydney
Camperdown, NSW 2006
Country [3] 306215 0
Australia
Secondary sponsor category [4] 306216 0
Individual
Name [4] 306216 0
Sue Kruske
Address [4] 306216 0
c/- Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000
Country [4] 306216 0
Australia
Secondary sponsor category [5] 306217 0
Individual
Name [5] 306217 0
Yvette Roe
Address [5] 306217 0
Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000
Country [5] 306217 0
Australia
Secondary sponsor category [6] 306218 0
Individual
Name [6] 306218 0
Donna Hartz
Address [6] 306218 0
Charles Darwin University (Sydney)
815 George St, Haymarket, NSW 2000
Country [6] 306218 0
Australia
Secondary sponsor category [7] 306219 0
Individual
Name [7] 306219 0
Carmel Nelson
Address [7] 306219 0
Institute for Urban Indigenous Health (IUIH)
22 Cox Road, Windsor,
QLD 4030
Country [7] 306219 0
Australia
Secondary sponsor category [8] 306220 0
Individual
Name [8] 306220 0
Mark Tracy
Address [8] 306220 0
The University of Sydney
Camperdown, NSW 2006
Country [8] 306220 0
Australia
Other collaborator category [1] 281327 0
Individual
Name [1] 281327 0
Luke Williamson
Address [1] 281327 0
Australian College of Midwives (ACM)
222 City Walk, Canberra ACT 2601
Country [1] 281327 0
Australia
Other collaborator category [2] 281328 0
Individual
Name [2] 281328 0
Jody Currie
Address [2] 281328 0
Aboriginal & Torres Strait Islander Community Health Service (ATSICHS) Brisbane
55 Annerley Road
Woolloongabba, QLD 4102
Country [2] 281328 0
Australia
Other collaborator category [3] 281329 0
Individual
Name [3] 281329 0
Leona McGrath
Address [3] 281329 0
Congress of Aboriginal & Torres Strait Islander Nurses and Midwives (CATSINaM)
Level 1/15 Lancaster Pl, Majura Park ACT 2609
Country [3] 281329 0
Australia
Other collaborator category [4] 281330 0
Individual
Name [4] 281330 0
Faye Worner
Address [4] 281330 0
Waminda South Coast Women's Health & Welfare Aboriginal Corportation
122 Kinghorne Street
Nowra, NSW 2541
Country [4] 281330 0
Australia
Other collaborator category [5] 281331 0
Individual
Name [5] 281331 0
Adrian Carson
Address [5] 281331 0
Institute for Urban Indigenous Health (IUIH)
22 Cox Road, Windsor,
QLD 4030
Country [5] 281331 0
Australia
Other collaborator category [6] 281332 0
Individual
Name [6] 281332 0
Cherisse Buzzacott
Address [6] 281332 0
Rhodanthe Lipsett Indigenous Midwifery Charitable Fund
4-6 Park Ln, Caringbah NSW 2229
Country [6] 281332 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304760 0
Aboriginal Health & Medical Research Committee (AH&MRC) of New South Wales (NSW)
Ethics committee address [1] 304760 0
Ethics committee country [1] 304760 0
Australia
Date submitted for ethics approval [1] 304760 0
Approval date [1] 304760 0
05/12/2018
Ethics approval number [1] 304760 0
1448/18
Ethics committee name [2] 306049 0
Mater Misericordiae Limited Human Research Ethics Committee
Ethics committee address [2] 306049 0
Ethics committee country [2] 306049 0
Australia
Date submitted for ethics approval [2] 306049 0
29/06/2018
Approval date [2] 306049 0
10/09/2018
Ethics approval number [2] 306049 0
HREC/18/MHS/107
Ethics committee name [3] 306053 0
Charles Darwin University HREC
Ethics committee address [3] 306053 0
Ethics committee country [3] 306053 0
Australia
Date submitted for ethics approval [3] 306053 0
Approval date [3] 306053 0
10/07/2019
Ethics approval number [3] 306053 0
H19054
Ethics committee name [4] 306054 0
University of Queensland HREC
Ethics committee address [4] 306054 0
Ethics committee country [4] 306054 0
Australia
Date submitted for ethics approval [4] 306054 0
Approval date [4] 306054 0
28/09/2018
Ethics approval number [4] 306054 0
2018001973/HREC/18/MHS/107
Ethics committee name [5] 306055 0
Illawarra Shoalhaven Local Health District (ISLHD) Health & Medical HREC/University of Wollongong
Ethics committee address [5] 306055 0
Ethics committee country [5] 306055 0
Australia
Date submitted for ethics approval [5] 306055 0
Approval date [5] 306055 0
18/12/2018
Ethics approval number [5] 306055 0
2018/472
Ethics committee name [6] 306056 0
Waminda Research Committee
Ethics committee address [6] 306056 0
Ethics committee country [6] 306056 0
Australia
Date submitted for ethics approval [6] 306056 0
Approval date [6] 306056 0
09/10/2018
Ethics approval number [6] 306056 0
none provided

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

Contacts
Principal investigator
Name 98118 0
Prof Susan Kildea
Address 98118 0
Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000
Country 98118 0
Australia
Phone 98118 0
+61 7 3169 4262
Fax 98118 0
Email 98118 0
sue.kildea@cdu.edu.au
Contact person for public queries
Name 98119 0
Susan Kildea
Address 98119 0
Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000
Country 98119 0
Australia
Phone 98119 0
+61 7 3169 4262
Fax 98119 0
Email 98119 0
sue.kildea@cdu.edu.au
Contact person for scientific queries
Name 98120 0
Susan Kildea
Address 98120 0
Molly Wardaguga Research Centre
Charles Darwin University
Level 11, East Building
410 Ann Street
Brisbane, Queensland 4000
Country 98120 0
Australia
Phone 98120 0
+61 7 3169 4262
Fax 98120 0
Email 98120 0
sue.kildea@cdu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseDeveloping and evaluating Birthing on Country services for First Nations Australians: the Building On Our Strengths (BOOSt) prospective mixed methods birth cohort study protocol.2023https://dx.doi.org/10.1186/s12884-022-05277-8
N.B. These documents automatically identified may not have been verified by the study sponsor.