Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000698673
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
30/06/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
30/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuity of care and enhanced support for women experiencing antenatal distress: A pilot randomised control trial and pragmatic program evaluation
Scientific title
Continuity of care and enhanced support for women experiencing antenatal distress: A pilot randomised control trial and pragmatic program evaluation
Secondary ID [1] 309735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal distress 330127 0
Condition category
Condition code
Mental Health 327008 327008 0 0
Depression
Mental Health 327009 327009 0 0
Anxiety
Reproductive Health and Childbirth 327155 327155 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This arm will see the same midwife, the research midwife (RM) at each antenatal visit, including birth, and their postpartum assessment(s). Baseline screening will occur when the participant is booking in the Antenatal Clinic. The women could be recruited up until 26 weeks gestation, and then will complete measures at Time 1: 36 weeks pregnant, Time 2: 8 weeks postpartum, and Time 3: 6 months postpartum. The RM would also check in with women about every two weeks from the baseline point. The communication between the midwife and participant will be a phone call or text message which will last approximately 10 to 20 minutes. Part of this continuity of care will involve the delivery of questionnaires at three points in time to evaluate women’s experience of care. These assessments will include assessments on the woman’s mental health (e.g. EPDS), perceptions of care (e.g. qualitative interviews), health indicators (e.g. routinely collected data), and connectedness to local services (e.g. referrals, appointments attended).
Services will be drawn from a pool of non-pharmacological interventions shown to have some efficacy in preventing postpartum depression or increasing service provision and engagement. This will include access to individualised care planning, home visiting, telephone support, the offer of debriefing after birth, social support and flexible care provision including outreach (Gamble et al., 2005; Grote et al., 2014; Matthey et al., 2004; Milani et al., 2015; Oommen et al., 2011; Reading, 2011).

The RM providing continuity of care will receive light-touch training in mental health first aid strategies such as receptive listening, maintaining a supportive attitude, and sensitively querying about maternal mood. The RM was trained in pregnancy loss and complications and has done small counselling courses e.g., small miracles Grief counselling, SIDS pregnancy loss workshop. The courses were a day each and occurred several years ago in a face-to-face classroom setting.

The intervention will take place at the Fairfield and Liverpool Hospital antenatal clinic. The intervention will include individual face-to-face and telehealth support. No fidelity measures will be used to monitor adherence to the intervention. The RM will have access to the women’s EMR records if there is a concern for follow up (e.g., they scored high on the surveys).

As mentioned above, qualitative interviews will be conducted to explore participants' perception of care. The interviews will be semi-structured using a study-specific interview guide and will be completed by a member of the research team with experience in conducting interviews of this kind. The interviews will take approximately 30 to 60 minutes to complete, and the interviews will be audio-recorded and transcribed. All participants will be asked to participate following their Time 3 survey, with a minimum of 10 interviews required for analysis and the maximum number involving all participants. A similar number of participants will be approached from each site.
Intervention code [1] 326174 0
Treatment: Other
Comparator / control treatment
The “usual care” arm of the study will involve routine midwifery visits in which clients will be seen by any of the midwifes available. While women in this group may also be recommended services (e.g. antenatal classes, telephone support), they will not receive continuity of care by midwives. Participation in this arm will involve the delivery of questionnaires at three points in time to evaluate women’s experience of care. These assessments will include assessments on the woman’s mental health (e.g. EPDS),
perceptions of care (e.g. qualitative interviews), health indicators (e.g. routinely collected data), and connectedness to local services (e.g. referrals, appointments attended).
The usual care will take place at the Fairfield and Liverpool Hospital antenatal clinic. The usual care will include individual face-to-face support.
Control group
Active

Outcomes
Primary outcome [1] 334868 0
Edinburgh Depression Scale (EPDS)
Timepoint [1] 334868 0
Baseline: When participant is recruited to the study e.g., 26-weeks pregnant or before
Time 1: 36-weeks pregnant
Time 2: 8 weeks postpartum
Time 3: 6 months postpartum
Primary outcome [2] 334869 0
The Kessler Psychological Distress Scale (K10)
Timepoint [2] 334869 0
Time 1: 36-weeks pregnant
Time 2: 8 weeks postpartum
Time 3: 6 months postpartum
Secondary outcome [1] 422290 0
Karitane Parenting Confidence Scale
Timepoint [1] 422290 0
Time 2: 8 weeks postpartum
Time 3: 6 months postpartum
Secondary outcome [2] 423091 0
Delivery details- date (taken from EMR data)
Timepoint [2] 423091 0
Delivery
Secondary outcome [3] 423092 0
Perceptions of care via qualitative interviews (semi-structured, one-on-one interview conducted online or face-to-face with a member of the research team)
Timepoint [3] 423092 0
Time 4: After 6 months postpartum
Secondary outcome [4] 423376 0
Delivery details- model of care (taken from EMR)
Timepoint [4] 423376 0
Delivery
Secondary outcome [5] 423377 0
Delivery details - complications (taken from EMR)
Timepoint [5] 423377 0
Delivery

Eligibility
Key inclusion criteria
- The participant is a pregnant woman attending the Fairfield and/or Liverpool Midwifery clinic, intending to continue attending the clinic for midwifery care
- Edinburgh Depression Scale (EPDS) below 13 and above 9. That is, an EPDS score of 10, 11, or 12 during the antenatal visit.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant plans to give birth at a different hospital

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by virtue of a division of roles, CI Heys will be in charge of participant recruitment, and will give CI Mendoza Diaz a name and ID codes, CI Mendoza Diaz will then be in charge of assigning each participant to a specific condition and notifying CI Heys which participant was allocated to which condition. As CI Mendoza Diaz will be blinded to the participants’ characteristics, he will be impartial as to which condition they are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation procedure will be followed whereby each patient is randomised to either condition. The sequence generation used for randomisation was created on https://www.randomizer.org/ and concealed from the recruiters, a process similar to that described in Eckardt, Braun & Kibele (2020). Participants were not stratified by risk profile.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
- Data cleaning and calculating scales
- Descriptive statistics
- Inferential statistics:
o T-tests (proof of concept)
o General linear models

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/05/2021
Date of last participant enrolment
Anticipated
Actual
19/05/2022
Date of last data collection
Anticipated
Actual
26/04/2023
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314040 0
University
Name [1] 314040 0
University of New South Wales
Country [1] 314040 0
Australia
Funding source category [2] 314041 0
Government body
Name [2] 314041 0
South Western Sydney Local Health District
Country [2] 314041 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 315786 0
Government body
Name [1] 315786 0
South Western Sydney Local Health District
Address [1] 315786 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
LIVERPOOL NSW 2170
Country [1] 315786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313070 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313070 0
Ethics committee country [1] 313070 0
Australia
Date submitted for ethics approval [1] 313070 0
16/02/2021
Approval date [1] 313070 0
01/03/2021
Ethics approval number [1] 313070 0
2020/ETH02780

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

Contacts
Principal investigator
Name 126886 0
Prof Valsamma Eapen
Address 126886 0
Level 3 AGSM
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 126886 0
Australia
Phone 126886 0
+61 2 96164205
Fax 126886 0
Email 126886 0
[email protected]
Contact person for public queries
Name 126887 0
Valsamma Eapen
Address 126887 0
Level 3 AGSM
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 126887 0
Australia
Phone 126887 0
+61 2 96164205
Fax 126887 0
Email 126887 0
[email protected]
Contact person for scientific queries
Name 126888 0
Valsamma Eapen
Address 126888 0
Level 3 AGSM
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 126888 0
Australia
Phone 126888 0
+61 2 96164205
Fax 126888 0
Email 126888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.