Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000830190p
Ethics application status
Submitted, not yet approved
Date submitted
17/05/2019
Date registered
7/06/2019
Date last updated
7/06/2019
Date data sharing statement initially provided
7/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
BirthCourse: An antenatal package of non-pharmacological pain-relief techniques for labour and birth to reduce the rates of caesarean section in labour and birth.
Scientific title
BirthCourse: An antenatal package of non-pharmacological pain-relief techniques for labour and birth to reduce the rates of caesarean section in labour and birth: a randomised control trial.
Secondary ID [1] 295336 0
Nil Known
Universal Trial Number (UTN)
U1111-1216-4512
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Maternal health during labour and birth 308587 0
Caesarean section 308588 0
Labour pain as reflected by use of epidural analgesia
 308589 0
Newborn health 308590 0
Condition category
Condition code
Reproductive Health and Childbirth 307540 307540 0 0
Antenatal care
Reproductive Health and Childbirth 307541 307541 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 307542 307542 0 0
Complications of newborn
Public Health 311410 311410 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BirthCourse: an antenatal education intervention, consisting of 5 different non-pharmacological (complementary therapy) techniques for the management of pain in normal labour and birth.

Materials – a booklet of materials is provided to participants during BirthCourse. The booklet contains information on the physiological processes of birth and explanations of the 5 non-pharmacological techniques taught during the course. This booklet has been specifically designed for the purpose of this study. Workshop checklists will be kept to monitor attendance and it is also possible to check if participants are accessing course materials by downloading them.

Procedures – The Birth Course education program is an intervention which introduces the concepts of: Physiology and hormones of birth, the Fear-Pain-Tension cycle, working with pain, the relaxation response, and uses the five techniques of: upright positions/yoga and movement for birth, acupressure techniques, guided visualisation, breathing techniques, and massage.

Who – The course will be delivered by an experienced childbirth educator (over 3 years) who also has a background in counselling and working with clients with anxiety and depression.

Mode of delivery – The program is run face-to-face in group sessions of aprox 8-12 couples per session.

Number of times, duration – participation in a 2-day or 4-module workshop from around 24-36 weeks gestation; practice of techniques until birth using the program materials; follow-up within 72 hours following birth; 6 week follow up questionnaire; longer term follow up if centres choose; some participants will participate in the in-depth interviews, not before 6 weeks post-partum.

Location – The BirthCourse antenatal education program will be delivered at Royal Prince Alfred Hospital, Sydney. Other hospitals may join at a later date and site specific approval will be sought.

We plan to introduce the RCT study to 400 women and their birth partners over a period of 24-36 months. Participants and their birth partners will be recruited from antenatal clinics at participating hospitals, from around 24 weeks of gestation and randomly allocated to attend the BirthCourse education program plus standard care or to standard care alone.
Intervention code [1] 301688 0
Prevention
Comparator / control treatment
Standard antenatal care - Usual care consists of hospital-based antenatal education. Classes include topics such as: pregnancy changes, exercise, signs of labour, unexpected outcomes in labour and birth, pharmacological pain management, managing labour and birth, newborn care and breast feeding, parenthood and baby’s first weeks.
Control group
Active

Outcomes
Primary outcome [1] 306520 0
Caesarean section - data accessed from patient medical records following birth
Timepoint [1] 306520 0
At birth
Secondary outcome [1] 348764 0
Maternal: Onset of labour
Timepoint [1] 348764 0
Spontaneous onset of labour or induced labour as identified through medical records
Secondary outcome [2] 348765 0
Maternal: duration of hospital stay
Timepoint [2] 348765 0
28 days post partum as stated in medical records
Secondary outcome [3] 348766 0
Infant: Apgar scores <7 at 1 minute and 5 minutes
Timepoint [3] 348766 0
At birth and early post partum
Secondary outcome [4] 348767 0
Infant: antibiotic administration.
Timepoint [4] 348767 0
28 days post partum as noted in medical records
Secondary outcome [5] 348768 0
Qualitative outcomes via interview will be ascertained for 15-20 quasi-randomly selected participants in the study group. The research questions that will be addressed in the interview sub-group will examine: reasons for use or lack of use of complementary medicines; perceived effectiveness of the program; satisfaction with birth and strategies for birth.
Timepoint [5] 348768 0
At one time point between 6-12 weeks post-partum
Secondary outcome [6] 348772 0
Personal control measures via questionnaires - Labour Agentry Scale (Hodnett et al 1987)
Timepoint [6] 348772 0
within 72 hours of birth
Secondary outcome [7] 348773 0
EPDS
Timepoint [7] 348773 0
Baseline at enrolment to the study (to check for any group differences) and assessed again at 6 weeks post partum to measure changes in perinatal mood
Secondary outcome [8] 348774 0
• Qualitative outcomes via focus groups for midwives from each of the study hospitals. The research will examine: perceived effectiveness of the program, integration into routine care, use during labour, barriers and enablers for use in the public health system.
Timepoint [8] 348774 0
within 6-12 months of completed recruitment
Secondary outcome [9] 348775 0
• Economic evaluation of the study in terms of outcomes related to comparisons of the two arms of the study using a decision tree analysis and based on AR-DRG codes and current funding models to hospitals.
The economic analysis will be a comparison between the study group and the control group calculating the cost of birth outcomes using the AR-DRG codes. These codes are a mutually exclusive categorization of medical outcomes which in obstetrics include mode of birth. These are the basis by which governments reimburse hospitals for costs incurred.
Timepoint [9] 348775 0
Within 24 months of completed recruitment
Secondary outcome [10] 370628 0
Maternal - failed induction of labour as noted in medical records
Timepoint [10] 370628 0
Onset of labour
Secondary outcome [11] 370629 0
Maternal - use of epidural block as noted in medical records
Timepoint [11] 370629 0
During labour
Secondary outcome [12] 370630 0
Maternal - other pharmacological pain relief as noted in medical records
Timepoint [12] 370630 0
During Labour
Secondary outcome [13] 370631 0
Maternal - augmentation of labour as noted in medical records
Timepoint [13] 370631 0
During labour
Secondary outcome [14] 370632 0
Maternal - instrumental vaginal birth as noted in medical records
Timepoint [14] 370632 0
During birth
Secondary outcome [15] 370633 0
Maternal - perineal trauma as noted in medical records
Timepoint [15] 370633 0
During birth
Secondary outcome [16] 370634 0
Maternal - postpartum haemorrhage as noted in medical records
Timepoint [16] 370634 0
Following birth
Secondary outcome [17] 370635 0
Length of labour - obtained from medical records
Timepoint [17] 370635 0
At birth
Secondary outcome [18] 370636 0
Gestational age at birth - noted within medical records
Timepoint [18] 370636 0
Birth
Secondary outcome [19] 370637 0
Time to fully establish breast feeding -noted within medical records
Timepoint [19] 370637 0
28 days postpartum
Secondary outcome [20] 370638 0
Infant - Re-admission within 28 days - noted within medical records
Timepoint [20] 370638 0
28 days post partum
Secondary outcome [21] 370639 0
Infant - resuscitation at birth - as noted in medical records
Timepoint [21] 370639 0
Birth and early postpartum
Secondary outcome [22] 370640 0
Infant - skin-to-skin contact during first hour after birth as noted in medical records
Timepoint [22] 370640 0
First hour of birth
Secondary outcome [23] 370641 0
Infant - breastfeeding within 1 hour of birth - as noted within medical records
Timepoint [23] 370641 0
Within 1 hour of birth
Secondary outcome [24] 370642 0
Infant - time to cord section - as noted within medical records
Timepoint [24] 370642 0
Birth and early post partum
Secondary outcome [25] 370643 0
Infant - respiratory distress - as noted within medical records
Timepoint [25] 370643 0
Birth and early post partum
Secondary outcome [26] 370644 0
Infant - admission to NICU/SCN - as noted within medical records
Timepoint [26] 370644 0
Birth and early post partum
Secondary outcome [27] 370645 0
Infant - cortisol administration - as noted within medical records
Timepoint [27] 370645 0
28 days post partum
Secondary outcome [28] 370646 0
Infant - duration of stay in special care unit - as noted in medical records
Timepoint [28] 370646 0
28 days post partum
Secondary outcome [29] 370647 0
Infant - duration of stay in hospital - noted within medical records
Timepoint [29] 370647 0
28 days post partum
Secondary outcome [30] 370648 0
Infant - birth weight - from medical records
Timepoint [30] 370648 0
Birth
Secondary outcome [31] 370649 0
Infant - any assisted ventilation - medical records
Timepoint [31] 370649 0
Birth and early post partum
Secondary outcome [32] 370650 0
Infant - medical investigations - medical records
Timepoint [32] 370650 0
28 days post partum
Secondary outcome [33] 370651 0
Perinatal mortality - medical records
Timepoint [33] 370651 0
28 days post partum

Eligibility
Key inclusion criteria
• Pregnant (with no congenital abnormalities) women (including: first time mothers (nulliparous)/ or women who have previously given birth (multiparous) – This is local choice i.e. each participating site can decide who to include, and this will be specified in their site specific study. The other sites where the trial will be performed as of yet unknown but we will seek the relevant ethics approval when they are identified).
The risk status of pregnant women is determined by a 'risk assessment' conducted during pregnancy. Women who are classified as low risk or moderate risk will be included.
(Risk status is determined by a scoring system at the hospital and measures can include age, marital status, socio-economic factors, smoking, threatened miscarriage, previous low birthweight baby, previous stillbirth, maternal weight and height. This scoring system enables clinicians to identify women at increased risk of adverse outcomes, and subsequently management options to reduce this risk).

Inclusion criteria:
• Singleton pregnancy, baby in vertex position, placenta not low lying (>20mm from the cervical os)
• No contraindications to vaginal birth
• Intending to have a vaginal birth
• Gestation between 24 and 36 weeks
• Mixed risk (local choice i.e. each participating site can decide who to include within their site specific study)
• Fragmented and continuity of care programs (stratified analysis)
• Sufficient English for participation in a two-day workshop,
• LOTE if educator or translator is able to provide full class in language of choice
Minimum age
17 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• High risk pregnancies
• Congenital abnormalities
• Any indication for planned caesarean section
• Participation in similar program of independent antenatal education (including for example, ‘CalmBirth’, ‘Hypnobirthing’, ‘Active Birthing’, ‘Yoga Birth’, ‘She Births', 'Genetle Birth', 'Lamaze' etc)

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)
Randomisation will be undertaken via the ‘Sealed Envelope’ website at the time of signed consent. Women will be randomised to the BirthCourse antenatal education intervention (plus usual care) or usual care alone. Randomisation will occur on a 1:1 basis, so there are equal numbers in each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken via the ‘Sealed Envelope’ website, with computer generated sequence allocation using random block design
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
Mixed methods, including in-depth interviews with women and partners and focus groups with midwives
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A range of statistical techniques will be employed for the data analysis including contingency table and t-test for univariate analysis of categorical and continuous data, respectively; chi-square test for trend analyses; multivariate logistic regression models to assess predictive factors for CM usage and association between CM usage and birth outcomes after adjusting for potential confounding by maternal factors.
Labour Agentry Scale measures will be analysed using t-tests for comparison of means.
Economic evaluation will utilise decision tree analysis of RCT outcomes using AR-DRG code (or equivalent) classifications.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13729 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 26475 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 299959 0
Government body
Name [1] 299959 0
NHMRC
Country [1] 299959 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
University of Notre Dame
160 Oxford Street
Darlinghurst
Sydney
2010
NSW
Country
Australia
Secondary sponsor category [1] 302681 0
Commercial sector/Industry
Name [1] 302681 0
BirthCourse
Address [1] 302681 0
9 Ryder Ct
Robina QLD 4226
Country [1] 302681 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300822 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 300822 0
Ethics committee country [1] 300822 0
Australia
Date submitted for ethics approval [1] 300822 0
17/05/2019
Approval date [1] 300822 0
Ethics approval number [1] 300822 0
Ethics committee name [2] 303348 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [2] 303348 0
Ethics committee country [2] 303348 0
Australia
Date submitted for ethics approval [2] 303348 0
17/05/2019
Approval date [2] 303348 0
Ethics approval number [2] 303348 0

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

Contacts
Principal investigator
Name 84838 0
Dr Kate Levett
Address 84838 0
University of Notre Dame Australia
160 Oxford Street
Darlinghurst
Sydney 2010
NSW
Country 84838 0
Australia
Phone 84838 0
+61 421991165
Fax 84838 0
Email 84838 0
[email protected]
Contact person for public queries
Name 84839 0
Kerry Sutcliffe
Address 84839 0
University of Notre Dame Australia
160 Oxford Street
Darlinghurst
Sydney 2010
NSW
Country 84839 0
Australia
Phone 84839 0
+61 451771723
Fax 84839 0
Email 84839 0
[email protected]
Contact person for scientific queries
Name 84840 0
Kerry Sutcliffe
Address 84840 0
University of Notre Dame Australia
160 Oxford Street
Darlinghurst
Sydney 2010
NSW
Country 84840 0
Australia
Phone 84840 0
+61 451771723
Fax 84840 0
Email 84840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data will be available after the de-identification process has been performed. The data will also be made available to a larger Prospective Meta Analysis.
When will data be available (start and end dates)?
Data will be available for 7 years following completion of the study.
Available to whom?
Data sharing will be at the discretion of the Primary sponsor and in line with a sound methodological reason to access the data.
Available for what types of analyses?
The data from this study will go into a larger Prospective Meta Analysis. Requests for data from elsewhere will be assessed on an individual basis.
How or where can data be obtained?
Those wanting access to the data will be required to complete a data access agreement and will be subject to the approval of the primary investigator.


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.