Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001545459
Ethics application status
Approved
Date submitted
14/10/2016
Date registered
9/11/2016
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skills-based childbirth and coaching preparation: self-efficacy and other psychological birth outcomes for first births.
Scientific title
Skills-based childbirth and coaching preparation: self-efficacy and other psychological birth outcomes for first births.
Secondary ID [1] 290334 0
nil known
Universal Trial Number (UTN)
U1111-1188-6956
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childbirth 300604 0
mental health 300846 0
Condition category
Condition code
Reproductive Health and Childbirth 300454 300454 0 0
Childbirth and postnatal care
Mental Health 300670 300670 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A skills based interventional package is posted to women, they complete it at home in their own time. The intervention is a anonymised version of "The Pink Kit for Birthing Better". The kit is sent out to women and contains 4 e-books, two audio CDs and a DVD. Women can choose when to read or listen to any of the content from 24 weeks gestation until full term. It is not personalised and participants will be asked what percentage of the course they think they used after the birth of their child.
Contents of the PInk Kit:
4 e-books:
1. Breath, language and
touch skills
2. Teamwork and managing
skills
3. Rationalization for basic
skills applicable for every
birth
4. Extra skills for
specific situations
1 DVD and contents
Skills to manage birth
process, eg:
Directed breathing
Map your pelvis
Teamwork
Skills to keep the body’s structure relaxed and open, for example:
Deep touch relaxation
Cervical relaxation
Hip lift
Sit bone spread
Pelvic clock
Kate’s cat

2 CDs and contents
How to prepare the
birth passage, eg:
internal work
Skills for each phase of a contraction


The second intervention is a collection of birth stories put together by the researchers to act as an active control.
Intervention code [1] 296146 0
Behaviour
Comparator / control treatment
There are two control groups. Participants randomised to the Active control condition are sent a book of birth stories. These were stories collated by the researchers which represent first person accounts of births, both simple and complicated.
There is also a treatment as usual control group. This group filled in the questionnaires at the same time points but were not given any intervention or provided with any treatment. The intervention provides no treatment, intervention or information for this group.
Both groups continue with their planned childbirth preparation on their own.
Control group
Active

Outcomes
Primary outcome [1] 299889 0
The Mackey Birth Satisfaction survey will be used to assess whether the intervention group had greater birth satisfaction than the active and TAU control groups. This is a simple ANOVA analysis.
Timepoint [1] 299889 0
Within two weeks of childbirth
Primary outcome [2] 299890 0
A comparison of scores on Childbirth self-efficacy scale between groups will be conducted using ANOVA.
Timepoint [2] 299890 0
At 36 weeks pregnant
Secondary outcome [1] 328400 0
Post-natal depression is measured using the Edinburgh Post-natal Depression Scale, no cut off is used a between group analysis is conducted.
Timepoint [1] 328400 0
6 months after childbirth
Secondary outcome [2] 329027 0
Family Life satisfaction was measured using the self-reported Family Life Satisfaction Scale. Groups are compared.
Timepoint [2] 329027 0
6 months post-birth
Secondary outcome [3] 329077 0
Midwives ratings. These were made for the purposes of the study.
Comparative work-related stress was measured on a visual analogue scale (VAS: 0 [much lower level of stress] -100 [much higher level of stress]) in response to the following questions. The questions were:

Comparative work related stress: Please use the following scale to rate how much less stress or how much more stress you experienced when caring for this client/patient and her partner compared to that you usually experience when caring for a client/patient and her partner by putting a stroke through the line.

Complications: Was there any expected physical issue (for example, breech position) or any other unexpected physical issue (only physical) which accounted for the stress you experienced?

Provision was also made for midwives to make comments.
Timepoint [3] 329077 0
These surveys were posted to midwives after they had stopped caring for the women in the trial ie. at least 6 weeks post-birth.

Eligibility
Key inclusion criteria
Must be pregnant and expecting a first child. Must have a partner. Must be less than 24 weeks pregnant. The partners of women who volunteered for the study were also invited to participate, there were no inclusion/exclusion criteria for partners. Midwives were sent a questionnaire at the conclusion of the study as informants rather than participants
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to speak english or understand questionnaires. No home address.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated to be 60 per group.
Quantitaive and qualitative analysis was used. ANOVAs and post-hoc regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
180
Accrual to date
Final
182
Recruitment outside Australia
Country [1] 8320 0
New Zealand
State/province [1] 8320 0

Funding & Sponsors
Funding source category [1] 294717 0
University
Name [1] 294717 0
University of Otago
Country [1] 294717 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 293562 0
None
Name [1] 293562 0
none
Address [1] 293562 0
none
Country [1] 293562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296137 0
Southern HDEC
Ethics committee address [1] 296137 0
Ethics committee country [1] 296137 0
New Zealand
Date submitted for ethics approval [1] 296137 0
01/02/2011
Approval date [1] 296137 0
17/03/2011
Ethics approval number [1] 296137 0
LRS/10/11/052

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

Contacts
Principal investigator
Name 69690 0
Ms Anne Howarth
Address 69690 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016
Country 69690 0
New Zealand
Phone 69690 0
+64 3 470 9451
Fax 69690 0
Email 69690 0
[email protected]
Contact person for public queries
Name 69691 0
Nicola Swain
Address 69691 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016
Country 69691 0
New Zealand
Phone 69691 0
+64 3 470 9451
Fax 69691 0
Email 69691 0
[email protected]
Contact person for scientific queries
Name 69692 0
Nicola Swain
Address 69692 0
Department of Psychological Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9016
Country 69692 0
New Zealand
Phone 69692 0
+64 3 470 9451
Fax 69692 0
Email 69692 0
[email protected]

No information has been provided regarding IPD availability


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.