Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000609752
Ethics application status
Approved
Date submitted
7/04/2022
Date registered
22/04/2022
Date last updated
22/04/2022
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of an Online Integrative Antenatal Education Programme on Labour and Birth Outcomes
Scientific title
The Impact of an Online Integrative Antenatal Education Programme on Labour and Birth Outcomes: A Randomised Control Trial on the Mid-North Coast of NSW
Secondary ID [1] 306871 0
Nil
Universal Trial Number (UTN)
U1111-1276-9154
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour 325960 0
Childbirth 325961 0
Antenatal care 325962 0
Health Education 326027 0
Condition category
Condition code
Reproductive Health and Childbirth 323276 323276 0 0
Antenatal care
Reproductive Health and Childbirth 323277 323277 0 0
Childbirth and postnatal care
Public Health 323278 323278 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm (50% of participants) will undertake an integrative antenatal education course delivered online.
Potential participants will recruited via an advertisement for the trial in the antenatal clinic. A QR code will direct them to a website where they will consent and register with the following details: due date of the baby, maternal age and the last 3 digits of the mothers mobile phone number
Participants in the intervention arm will be given a link to an online course via email and asked to complete the 4 core modules (roughly 10 hrs) of the course in their own time, at any location, prior to birth.
For both the intervention and control arms, the trial is offered not as a replacement to usual care (such as public group antenatal classes) but IN ADDITION to whatever usual care the participants would have otherwise undertaken.
This is all that participants in the intervention arm are required to do.
Participants randomised to the control arm of the study will not undertake any activity other than usual care.
Details of the degree of completion of the course will be collected by the online course administrator and sent to the research team to monitor adherence. Non-completion will require data to be omitted from analysis of birth outcomes.
The intervention is only provided once during the course of the pregnancy
Participants can use the knowledge they obtain at their discretion and are not required to utilise any techniques taught in the course if not so desired
Birth outcome data will be accessed through a public database which stores maternity data from the mid-north coast and collection of this data does not require action by the participant

The 4 Core Modules of the course are described below and are delivered in a series of short videos running roughly 10 hours total. There is also additional content in the form of handbooks, visualisations, videos and downloads.
Module 1: Learning to trust the body
Nutrition; hormones; mind-body connection; transforming fear; nervous system; relaxation; the culture of birth; uterine layers; active birth and optimal positioning, and yoga demonstration
Module 2: Discovering practical tools
Breathing techniques ; mind and birth as meditation; altering pain perception; massage techniques and acupressure
Module 3: Labour Stages and Strategies
How Labour Begins; pre-labour and active labour; breathing techniques for transition and second stage of labour; third stage of labour; birth preferences; B.R.A.N.D: Conscious Decision Making; birth documentary; 3 ways to labour; setting up for birth at home and hospital; spiralling; perineal massage; rebozo demonstration; full birth rehearsal
Module 4: Breastfeeding & Early Parenting
Lotus flower breath; baby-led attachment; breastfeeding tips; breastfeeding positions, tiredness & safe sleeping; baby communication and language and conscious parenting
Visualisations, videos and downloads
1 x Prenatal Yoga Class Download, 6 x Visualisations, 20 x Birth Story Videos, 2 x Actual Births at Home & Hospital; Breastfeeding Resources; Q&A forums; Podcast interviews
Intervention code [1] 323327 0
Prevention
Comparator / control treatment
Usual antenatal care. Which in this circumstance is any non-private antenatal education classes that the participant is offered as part of routine care at the public hospital
Control group
Active

Outcomes
Primary outcome [1] 331011 0
Rate of normal vaginal birth, among women who labour (i.e., excluding birth by elective caesarean section).
The unique identifier entered by participants (due date, maternal age and the last 3 digits of the mother's mobile phone number) will be used by the NSW eMaternity data custodian to identify the participant and extract their birth outcome data. This can be linked to their completion of the course online by the unique identifier details added by the participant on registration.
Timepoint [1] 331011 0
Birth
Secondary outcome [1] 408482 0
Pain management (e.g., epidural anaesthesia, nitrous oxide etc.)
Public Hospital eMaternity data extracted by the Mid-North Coast data custodian
Timepoint [1] 408482 0
Birth
Secondary outcome [2] 408646 0
Induction/augmentation of labour
Public Hospital eMaternity data extracted by the Mid-North Coast data custodian
Timepoint [2] 408646 0
Birth
Secondary outcome [3] 408647 0
Instrumental intervention (e.g., forceps or vacuum)
Public Hospital eMaternity data extracted by the Mid-North Coast data custodian
Timepoint [3] 408647 0
Birth
Secondary outcome [4] 408648 0
Perineal trauma (e.g., episiotomy or tear)
Public Hospital eMaternity data extracted by the Mid-North Coast data custodian
Timepoint [4] 408648 0
Birth
Secondary outcome [5] 408649 0
Any newborn or maternal special care
Public Hospital eMaternity data extracted by the Mid-North Coast data custodian
Timepoint [5] 408649 0
Birth

Eligibility
Key inclusion criteria
18 years or older
Availability to participate in 10hrs of an online course at between 24 to 30 weeks’ gestation
A singleton pregnancy
A low-risk pregnancy (no pre-existing medical or obstetric complications - se exclusion criteria)
Fluency in English sufficient to participate in an online course
Access to a computer and the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
A risk associated with pregnancy such as
• pre-pregnancy diabetes or high blood pressure
• diabetes or high blood pressure diagnosed during my pregnancy
• major health conditions requiring regular prescription medication
• a condition with higher risk of premature birth such as a short cervix or recurrent episodes of vaginal bleeding
Enrolment or intention to enrol in another private midwifery programme or birth preparation course
Previously randomisation to this trial
No access to a computer or the internet
non-fluent in English
Absence of a “support person”
Planned caesarean section

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat analysis will be used to examine primary and secondary outcomes. Chi squared and t-tests will be used for univariate analysis of categorical and continuous data respectively and results will be reported as relative risk with a 95% confidence interval. The analysis will be undertaken blind to group allocation and by a researcher not affiliated with the group delivering the intervention. Data will be analysed using R

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/04/2022
Actual
Date of last participant enrolment
Anticipated
25/01/2024
Actual
Date of last data collection
Anticipated
25/04/2024
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22151 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 22152 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment postcode(s) [1] 37295 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 37296 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 311187 0
Commercial sector/Industry
Name [1] 311187 0
The Birthing Institute Pty Ltd
Country [1] 311187 0
Australia
Primary sponsor type
University
Name
UNSW, Sydney - Rural Clinical Campus
Address
26 Highfield Circuit, Port Macquarie, NSW 2444
Country
Australia
Secondary sponsor category [1] 312548 0
None
Name [1] 312548 0
Address [1] 312548 0
Country [1] 312548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310720 0
North Coast Local Health District Ethics Committee
Ethics committee address [1] 310720 0
North Coast Local Health District Ethics Committee
Murwillumbah District Hospital
PO Box 821
Murwillumbah, NSW 2484
Ethics committee country [1] 310720 0
Australia
Date submitted for ethics approval [1] 310720 0
06/12/2021
Approval date [1] 310720 0
07/02/2022
Ethics approval number [1] 310720 0
HREA334 2021/ETH11167 PID02322

Summary
Brief summary
In Australia, antenatal education programs are mostly unregulated and educators do not require formal qualifications that ensure evidence-based teaching (Downer, Young et al. 2020). In a climate where birth interventions are increasing (AIHW 2018), antenatal education can play a role in helping women to make evidence-based decisions about labour and birth that may improve outcomes for themselves and their baby. Randomised control trials (RCTs) of antenatal education interventions are diverse, and largely weakened by low numbers and poor design. The strongest suggestion so far that antenatal education can improve birth outcomes was an RCT of 176 births in Sydney, Australia where women undergoing a an antenatal program based on the SheBirths® course, compared to controls, had 65% less epidural anaesthesia, 44% less caesarean sections and 50% less medical augmentation/induction (Levett, 2016). In order to make generalisations about the impact of this antenatal education course, the results need to be replicated in other populations. The proposed project will be an open-label, assessor-blind RCT of the online, self-administered adaptation of SheBirths® antenatal education program in Port Macquarie and Coffs Harbour Base Hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118630 0
Dr Emma Schofield
Address 118630 0
School of Clinical Medicine, UNSW Medicine & Health
Port Macquarie Clinical Campus
26 Highfields Circuit
Room 102, Level 1, Shared Health Research and Education Blg
Port Macquarie, NSW 2444
Country 118630 0
Australia
Phone 118630 0
+61425221915
Fax 118630 0
Email 118630 0
e.schofield@unsw.edu.au
Contact person for public queries
Name 118631 0
Dr Emma Schofield
Address 118631 0
School of Clinical Medicine, UNSW Medicine & Health
Port Macquarie Clinical Campus
26 Highfields Circuit
Room 102, Level 1, Shared Health Research and Education Blg
Port Macquarie, NSW 2444
Country 118631 0
Australia
Phone 118631 0
+61425221915
Fax 118631 0
Email 118631 0
e.schofield@unsw.edu.au
Contact person for scientific queries
Name 118632 0
Dr Emma Schofield
Address 118632 0
School of Clinical Medicine, UNSW Medicine & Health
Port Macquarie Clinical Campus
26 Highfields Circuit
Room 102, Level 1, Shared Health Research and Education Blg
Port Macquarie, NSW 2444
Country 118632 0
Australia
Phone 118632 0
+61425221915
Fax 118632 0
Email 118632 0
e.schofield@unsw.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
No current ethics approval to do so. However data associated with a publication will be available according to journal requirements.


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.