Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000111370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/06/2025
Date registered
Help: Date registered
29/01/2026
Date last updated
Help: Date last updated
29/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Dried Blood Spot (DBS) for the detection of biomarkers associated with Perinatal Depression
Scientific title
Evaluation of a Dried Blood Spot (DBS) for the detection of biomarkers associated with Perinatal Depression in pregnant and postnatal women
Additional trial identifiers [1] 314775 0
Nil
Universal Trial Number (UTN)
Trial acronym
DBS
Related trial records

Health condition
Health condition(s) studied:
perinatal depression 338007 0
Condition category
Condition code
Mental Health 334321 334321 0 0
Depression
Reproductive Health and Childbirth 336446 336446 0 0
Antenatal care
Reproductive Health and Childbirth 336447 336447 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Capitainer B Dried Blood Spot (DBS) test involves the removal of blood from a participant using a finger prick blood sampling device. The blood is then immediately applied to a pre-prepared DBS filter paper for drying. This paper card is then collected for analysis. This process takes less than 10 seconds to complete.
The DBS test will be evaluated for its ability to predict perinatal depression in a hospital setting. Women will be shown how to use the finger prick blood sampling device at their routine second trimester appointment by a member of the research team. The first sample will be conducted with a member of the research team to ensure participants' understand how to use the device. They will be asked to conduct blood sampling using the device in their home at 6 weeks postpartum and 6 months postpartum. These samples will be posted to the research team for analysis.
Intervention code [1] 331376 0
Early detection / Screening
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341982 0
Perinatal depression
Timepoint [1] 341982 0
24 weeks gestation, 6 weeks postpartum, 6 months postpartum
Primary outcome [2] 343097 0
Perinatal Depression
Timepoint [2] 343097 0
24 weeks gestation, 6 weeks postpartum, 6 months postpartum
Primary outcome [3] 343098 0
Depression
Timepoint [3] 343098 0
24 weeks gestation, 6 weeks postpartum, 6 months postpartum
Secondary outcome [1] 449226 0
User satisfaction
Timepoint [1] 449226 0
24 weeks gestation
Secondary outcome [2] 453394 0
Quality of life
Timepoint [2] 453394 0
24 weeks gestation, 6 weeks postpartum, 6 months postpartum
Secondary outcome [3] 453395 0
Feasibility
Timepoint [3] 453395 0
6 months postpartum
Secondary outcome [4] 456501 0
Feasibility
Timepoint [4] 456501 0
6 months postpartum

Eligibility
Key inclusion criteria
Women attending the public or private maternity clinics at Mater Mothers’ Hospital in South Brisbane or Catherine’s House for Mothers, Babies and Families; pregnant prior to 24 weeks gestation; aged 18 years or above; have English proficiency.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Women who have inability to access a device to receive email or text messages and to complete online surveys; Unable to provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
28/05/2027
Actual
Date of last data collection
Anticipated
26/11/2027
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319330 0
Commercial sector/Industry
Name [1] 319330 0
Ketim Technologies
Country [1] 319330 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae
Address
Country
Australia
Secondary sponsor category [1] 321815 0
Commercial sector/Industry
Name [1] 321815 0
Ketim Technologies
Address [1] 321815 0
Country [1] 321815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317912 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 317912 0
Ethics committee country [1] 317912 0
Australia
Date submitted for ethics approval [1] 317912 0
30/06/2025
Approval date [1] 317912 0
11/12/2025
Ethics approval number [1] 317912 0

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

Contacts
Principal investigator
Name 142530 0
Dr Grace Branjerdporn
Address 142530 0
Mater Hospital, Level 5, 41 Annerley Road Campus, South Brisbane, Qld 4101
Country 142530 0
Australia
Phone 142530 0
+61 408141234
Fax 142530 0
Email 142530 0
[email protected]
Contact person for public queries
Name 142531 0
Dr Grace Branjerdporn
Address 142531 0
Mater Hospital, Level 5, 41 Annerley Road Campus, South Brisbane, Qld 4101
Country 142531 0
Australia
Phone 142531 0
+61 408141234
Fax 142531 0
Email 142531 0
[email protected]
Contact person for scientific queries
Name 142532 0
Dr Clarissa Yates
Address 142532 0
Ketim Technologies, Level 3/488 Queen St, Brisbane City, QLD 4000
Country 142532 0
Australia
Phone 142532 0
+61 405536373
Fax 142532 0
Email 142532 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to the sensitive nature of the data



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Other    DBS_CAPITAINER-B_Instructions.pdf


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.