Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000697583
Ethics application status
Approved
Date submitted
1/05/2024
Date registered
31/05/2024
Date last updated
10/11/2024
Date data sharing statement initially provided
31/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Canberra Family Study: Engaging with new parents to drive improvements in maternity service quality and family healthcare outcomes.
Scientific title
The Canberra Family Study: A prospective study of new parents following the birth of their child to improve maternity service and family healthcare outcomes.
Secondary ID [1] 312066 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy models of care 333678 0
Supplement use in pregnancy 333680 0
Birth experience 333681 0
Breastfeeding 333682 0
Sleep disorders in pregnancy 333683 0
Parenting confidence 333684 0
Chronic disease management in the community 333685 0
Welfare of partners and fathers 333686 0
High risk pregnancy follow up 333687 0
Perinatal mental health in new parents 333688 0
Condition category
Condition code
Reproductive Health and Childbirth 330363 330363 0 0
Antenatal care
Reproductive Health and Childbirth 330364 330364 0 0
Breast feeding
Reproductive Health and Childbirth 330365 330365 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 330366 330366 0 0
Fetal medicine and complications of pregnancy
Mental Health 330367 330367 0 0
Other mental health disorders
Public Health 330508 330508 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Following the birth of the baby (between D1 and day 28 postpartum), new mothers and their partners will complete a questionnaire containing several validated tools to assess models of care, advocacy, mental health symptoms, birth experience, breastfeeding, parenting, sleep, and chronic disease management.. They will also have the pregnancy record and newborn record audited
Intervention code [1] 328508 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338133 0
Satisfaction with pregnancy models of care
Timepoint [1] 338133 0
Once between Day 0 to 28 postnatal
Primary outcome [2] 338134 0
Satisfaction with ability to advocate for healthcare outcomes
Timepoint [2] 338134 0
Once between Day 0 to 28 postnatal
Primary outcome [3] 338135 0
Evidence based use of supplements in pregnancy
Timepoint [3] 338135 0
Once between Day 0 to 28 postnatal
Secondary outcome [1] 434625 0
Childbirth experience
Timepoint [1] 434625 0
Once between Day 0 to 28 postnatal
Secondary outcome [2] 434626 0
Parental efficacy
Timepoint [2] 434626 0
Once between Day 0 to 28 postnatal
Secondary outcome [3] 434627 0
Social support levels
Timepoint [3] 434627 0
Once between Day 0 to 28 postnatal
Secondary outcome [4] 434628 0
Breastfeeding confidence
Timepoint [4] 434628 0
Once between Day 0 to 28 postnatal
Secondary outcome [5] 434629 0
Long term capacity to manage chronic disease in the community
Timepoint [5] 434629 0
Once between Day 0 to 28 postnatal
Secondary outcome [6] 434630 0
Sleep outcomes
Timepoint [6] 434630 0
Once between Day 0 to 28 postnatal
Secondary outcome [7] 434632 0
Rates of depression in partners of women with a new baby
Timepoint [7] 434632 0
Once between Day 0 to 28 postnatal

Eligibility
Key inclusion criteria
New mother who delivered a liveborn baby with 28 days and their partner (if applicable)
Minimum age
15 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Birth of a stillborn baby or baby less than 24 weeks gestation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Simple statistics will be performed to describe the data set. Primary and secondary analyses for each substudy shall be as specified in the protocol above. Descriptive statistics will be applied. Discrete data presented as N (%) and continuous data as mean (SD) if normally distributed and median (IQR) if nonparametric. Discrete data will be compared using Chi square tests and continuous data using non paired t-test, unless nonparametric, in which case Mann Whitney U test will be applied. Univariate and multivariate analyses will be performed with multivariate analysis including those relevant variables significant at a p<0.1 in univariate analysis. A p-value of <0.05 will be deemed significant. Power calculation for each of the 11 substudies has been prospectively determined in the study protocol.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/10/2024
Actual
28/10/2024
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1000
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 316424 0
Hospital
Name [1] 316424 0
The Canberra Hospital
Country [1] 316424 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 318594 0
University
Name [1] 318594 0
University of Notre Dame Australia
Address [1] 318594 0
Country [1] 318594 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315219 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 315219 0
Ethics committee country [1] 315219 0
Australia
Date submitted for ethics approval [1] 315219 0
01/06/2024
Approval date [1] 315219 0
04/09/2024
Ethics approval number [1] 315219 0
2024.LRE.00124

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

Contacts
Principal investigator
Name 134022 0
Prof Julie Quinlivan
Address 134022 0
Institute for Health Research University of Notre Dame Australia 32 Mouat St, Fremantle WA 6160
Country 134022 0
Australia
Phone 134022 0
+61 8 9433 0533
Fax 134022 0
Email 134022 0
julie.quinlivan@nd.edu.au
Contact person for public queries
Name 134023 0
Julie Quinlivan
Address 134023 0
Institute for Health Research University of Notre Dame Australia 32 Mouat St, Fremantle WA 6160
Country 134023 0
Australia
Phone 134023 0
+61 8 9433 0533
Fax 134023 0
Email 134023 0
julie.quinlivan@nd.edu.au
Contact person for scientific queries
Name 134024 0
Julie Quinlivan
Address 134024 0
Institute for Health Research University of Notre Dame Australia 32 Mouat St, Fremantle WA 6160
Country 134024 0
Australia
Phone 134024 0
+61 8 9433 0533
Fax 134024 0
Email 134024 0
julie.quinlivan@nd.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
Not funded to provide


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.