Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000241538
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
11/03/2024
Date last updated
11/03/2024
Date data sharing statement initially provided
11/03/2024
Date results information initially provided
11/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Childbirth self-efficacy and birth related posttraumatic stress disorder symptoms: An online childbirth education randomised controlled trial for mothers
Scientific title
Childbirth self-efficacy and birth related posttraumatic stress disorder symptoms: An online childbirth education randomised controlled trial for mothers
Secondary ID [1] 311472 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Birth related posttraumatic stress disorder 332792 0
Public Health 333002 0
Condition category
Condition code
Reproductive Health and Childbirth 329515 329515 0 0
Childbirth and postnatal care
Mental Health 329516 329516 0 0
Other mental health disorders
Public Health 329697 329697 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were recruited between May 2021 and July 2021 on dedicated Facebook and Instagram pages titled “Birthing in Australia”. Participants were invited to participate in a four-stage study about pregnancy, birth and early parenting. The information statement outlined the activity and commitment for each group and advised that they would be randomised into one of the three groups. At the end of the first survey (i.e., Time 1) each participant was randomly allocated into one of the three groups using Qualtrics random allocation. The online course group (intervention) were asked to complete the online version of a psychoprophylactic centered birthing course designed by She Births®. She Births® is an Australian designed course that has previously be shown to reduce interventions such as caesareans and epidurals during birth. The course focuses on birth as a natural physiological process using active birthing strategies, including, yoga, massage, acupressure, breathing, and relaxation techniques to manage pain and facilitate labour progression. It covers four modules: 1): Learning to trust the body; 2): Discovering practical tools; 3) Labour stages and strategies; and 4) Breastfeeding and early parenting, which involve interactive activities, reading material and videos.. The course is self paced with a around 10 hours of content or approximately one hour per week for 12 weeks. Details can be found about the course at shebirths.com.

Intervention code [1] 327927 0
Prevention
Comparator / control treatment
Two control groups.
Pregnancy as usual (passive control) - reference comparator
Birth stories (active control) - reading stories about birth. The booklet comprised of twelve birth stories with a range of birth types including unassisted vaginal birth, water birth, home birth, instrumental birth and caesarean birth and was designed specifically for this study. The purpose of the active control was to check if the act of having an activity to complete would influence outcomes.
Control group
Active

Outcomes
Primary outcome [1] 337311 0
Childbirth self-efficacy
Timepoint [1] 337311 0
12-23 weeks pregnant - once during this period
36 weeks pregnant - once
Primary outcome [2] 337312 0
Posttraumatic stress disorder symptoms
Timepoint [2] 337312 0
6 weeks postnatal - primary timepoint
6 months postnatal
Secondary outcome [1] 431412 0
Perinatal depression
Timepoint [1] 431412 0
12-23 weeks pregnant - once during this time period
36 weeks pregnant
6 weeks postnatal
6 months postnatal
Secondary outcome [2] 431413 0
Mother-infant bonding
Timepoint [2] 431413 0
6 weeks postnatal
6 months postnatal

Eligibility
Key inclusion criteria
Participants were required to be aged 18 or over, English speaking, residing in Australian with a low-risk pregnancy (between 12 to 23 weeks pregnant) and planning a vaginal birth.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer software
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
5/07/2021
Date of last data collection
Anticipated
Actual
23/07/2022
Sample size
Target
120
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315757 0
Government body
Name [1] 315757 0
Department of Education: Australian Research Training Program
Country [1] 315757 0
Australia
Primary sponsor type
University
Name
University of New England
Address
Country
Australia
Secondary sponsor category [1] 317882 0
None
Name [1] 317882 0
Address [1] 317882 0
Country [1] 317882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314620 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 314620 0
http://www.une.edu.au/research/res-services/rdi/ethics/hre/human-research-ethics-committee
Ethics committee country [1] 314620 0
Australia
Date submitted for ethics approval [1] 314620 0
30/09/2020
Approval date [1] 314620 0
13/01/2021
Ethics approval number [1] 314620 0

Summary
Brief summary
The study is a randomised control trial (RCT) testing a self-directed online childbirth education course aimed at improving a mother’s childbirth self-efficacy and reducing the onset and/or severity of birth related PTSD symptoms, and in turn improving mother-infant bonding. The experiment was conducted as a primary prevention study by recruiting women during pregnancy. It was hypothesised that the intervention group would report greater prenatal childbirth self-efficacy, less postnatal birth related PTSD symptoms and greater mother-infant bonding than in control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132186 0
Prof Einar Thorsteinsson
Address 132186 0
University of New England, Elm Ave, Armidale NSW 2351
Country 132186 0
Australia
Phone 132186 0
+61 2 6773 2587
Fax 132186 0
Email 132186 0
ethorste@yune.edu.au
Contact person for public queries
Name 132187 0
Einar Thorsteinsson
Address 132187 0
University of New England, Elm Ave, Armidale NSW 2351
Country 132187 0
Australia
Phone 132187 0
+61 2 6773 2587
Fax 132187 0
Email 132187 0
ethorste@yune.edu.au
Contact person for scientific queries
Name 132188 0
Einar Thorsteinsson
Address 132188 0
University of New England, Elm Ave, Armidale NSW 2351
Country 132188 0
Australia
Phone 132188 0
+61 2 6773 2587
Fax 132188 0
Email 132188 0
ethorste@yune.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data of primary outcomes
When will data be available (start and end dates)?
Prior to submission for publication and made available indefinitely
Available to whom?
Public
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By contacting principal investigator at ethorste@une.edu.au


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.