Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001353280
Ethics application status
Approved
Date submitted
28/07/2018
Date registered
10/08/2018
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
My Birth Course: An antenatal course of Complementary Medicine (CM) techniques for labour and birth for women having their first baby: a randomized controlled trial.
Scientific title
My Birth Course: An antenatal package of Complementary Medicine (CM) techniques for labour and birth examining epidural use in primiparous women: a randomized controlled trial.
Secondary ID [1] 295671 0
None
Universal Trial Number (UTN)
U1111-1216-4512
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Pregnancy 309036 0
Labour 309037 0
Childbirth 309038 0
Medical interventions childbirth 309039 0
Condition category
Condition code
Reproductive Health and Childbirth 307929 307929 0 0
Antenatal care
Reproductive Health and Childbirth 307930 307930 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
My Birth Course is an antenatal education package consisting of 5 different non-pharmacological (complementary therapy) techniques for the management of pain in normal labor and birth. The workshops are educational sessions with interactive practice of techniques learned over the course. The following concepts and techniques are introduced to the woman during the course: the physiology of birth, the fear-pain-tension cycle, working with pain, the relaxation response, guided visualization and relaxation, active birth- movement, yoga and positions for birth, accupressure, breathing and massage techniques.
Duration of treatment: Participation in a 2-day weekend or a series of 4x (2.5h) evening workshops from 24-36 weeks gestation. Participants can choose which of the scheduled workshops (whether weekend or evening) they wish to attend. Participants document a practice worksheet outlining the tools and techniques (when/where/with whom) they will practice to prepare for labour and birth. Participants are instructed to practice their chosen technique/s regularly but are not prescribed any specific duration or frequency of time to practice.
The workshop will run twice per month over 10-12 months or until recruitment has been achieved. The workshops will be held at the University of South Australia (west campus) Health Clinic. The workshops will be delivered by expert midwifery educators with a minimum of 5 years experience each.
Follow-up will occur within 72 hours of birth. At this time point participants will self report time spent practicing the (complementary therapies) techniques used for labour and birth.
Intervention code [1] 301994 0
Prevention
Comparator / control treatment
Standard care alone; The free antenatal classes offered to all women at the Women's and Children's Hospital: Preparing for Birth and Parenting http://www.wch.sa.gov.au/services/az/divisions/wab/antenatal_education.html
The program is designed and run by educators from the Women's and Children's Hospital
Control group
Active

Outcomes
Primary outcome [1] 306903 0
Epidural rate as recorded in the medical records
Timepoint [1] 306903 0
At birth
Primary outcome [2] 306910 0
Maternal outcome: length of labour (first stage, second stage, third stage) as recorded in the woman's medical records
Timepoint [2] 306910 0
During labour and birth
Secondary outcome [1] 350066 0
Infant resuscitation at birth from medical records
Timepoint [1] 350066 0
At birth and early postpartum ( <= 72 hours after birth)
Secondary outcome [2] 350067 0
A change in score in the validated "Attitude to Birth Questionnaire"
Timepoint [2] 350067 0
Prior to and after antenatal course (both groups)
Secondary outcome [3] 350068 0
The "Capture My Mood" questionnaire ; difference in score
Timepoint [3] 350068 0
At antenatal course completion (both groups)
Secondary outcome [4] 350069 0
Labour agentry questionnaire (personal control measures)
Timepoint [4] 350069 0
Within 72 hours of birth
Secondary outcome [5] 350443 0
The validated Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)
Timepoint [5] 350443 0
At antenatal course completion (both groups)
Secondary outcome [6] 350448 0
Infant admission to NICU/SCN from medical records
Timepoint [6] 350448 0
At birth <72h
Secondary outcome [7] 350449 0
mode of birth assisted or cesarean section from medical records
Timepoint [7] 350449 0
time of birth <72h

Eligibility
Key inclusion criteria
• Gestational age between 24 and 36 weeks of completed pregnancy
• Primiparous
• Singleton pregnancies
• Low to moderate risk as defined by Australian College of Midwives referral guidelines
• Women will have sufficient English for participation in a the workshops
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• High risk pregnancies
• Congenital abnormalities
• Participation in similar program of complementary antenatal education including ‘Calm Birth’, ‘Hypnobirthing’, ‘Active Birthing’ etc.)
• Participation in midwifery group practice (1:1 Midwifery continuity of care model)

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)
Once eligible women are consented for the study, randomisation will be undertaken via the ‘Sealed Envelope’ website, with women randomised to CM education program (plus usual care) or usual care alone. Randomisation will occur on a 1:1 basis. Recruitment will take place over 12 months (August 2018-August 2019) or until the target number of participants has been reached.
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be by intention to treat (ITT) for primary and secondary outcome data. 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. Analyses will be performed in STATA and/or SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/08/2018
Actual
4/09/2018
Date of last participant enrolment
Anticipated
8/06/2021
Actual
Date of last data collection
Anticipated
8/10/2021
Actual
Sample size
Target
200
Accrual to date
167
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11528 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 23554 0
5006 - North Adelaide
Recruitment postcode(s) [2] 23555 0
5006 - North Adelaide Melbourne St

Funding & Sponsors
Funding source category [1] 300253 0
University
Name [1] 300253 0
University of South Australia
Country [1] 300253 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 299674 0
None
Name [1] 299674 0
Address [1] 299674 0
Country [1] 299674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301074 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 301074 0
Women's & Children's Hospital
Level 2 Samuel Way Building
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 301074 0
Australia
Date submitted for ethics approval [1] 301074 0
14/02/2018
Approval date [1] 301074 0
29/05/2018
Ethics approval number [1] 301074 0
HREC/18/WCHN/19
Ethics committee name [2] 301081 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 301081 0
University of South Australia
GPO Box 2471
South Australia 5001
Ethics committee country [2] 301081 0
Australia
Date submitted for ethics approval [2] 301081 0
02/06/2018
Approval date [2] 301081 0
19/06/2018
Ethics approval number [2] 301081 0
201343

Summary
Brief summary
The aim of this research is to translate the low-cost ‘Integrative Medicine for Labour & Birth Program’ (My Birth Course) into end-user benefit and to inform health service delivery. The study will be conducted as a randomised controlled trial (RCT). Randomisation will occur between 24-36 weeks’ gestation. Women will be enrolled into the My Birth Course (antenatal education program), in addition to standard care, or receive standard care alone. This RCT will contribute to a prospective meta-analysis design to assess clinical effectiveness and quantify resource use that will affect translation into practice and sustainability. This study extends the finding of the original RCT conducted in Sydney, Australia which demonstrated significant reductions in caesarean section and medical interventions. The unique contribution of this proposal is to extend the generalisability of the findings by recruiting women from a more diverse group of women at a different hospital to determine the real-world effectiveness of an antenatal education intervention when it is delivered through a range of maternity units in Australia and internationally.
Trial website
Trial related presentations / publications
Public notes
At study completion results will contribute to one of five sites contributing to the pooled data prospective meta-analysis study design. Pooled data will be analysed by the national investigator (KL) of the original trial as part of the Cochrane Prospective Meta-Analysis Methods Group http://methods.cochrane.org/pma/welcome

Contacts
Principal investigator
Name 85794 0
Dr Julie Fleet
Address 85794 0
University of South Australia
School of Nursing and Midwifery
GPO Box 2471
Adelaide, South Australia 5001
Country 85794 0
Australia
Phone 85794 0
+61 8 8302 1845
Fax 85794 0
Email 85794 0
julie.fleet@unisa.edu.au
Contact person for public queries
Name 85795 0
Dr Julie Fleet
Address 85795 0
University of South Australia
School of Nursing and Midwifery
GPO Box 2471
Adelaide, South Australia 5001
Country 85795 0
Australia
Phone 85795 0
+61 8 8302 1845
Fax 85795 0
Email 85795 0
julie.fleet@unisa.edu.au
Contact person for scientific queries
Name 85796 0
Dr Julie Fleet
Address 85796 0
University of South Australia
School of Nursing and Midwifery
GPO Box 2471
Adelaide, South Australia 5001
Country 85796 0
Australia
Phone 85796 0
+61 8 8302 1845
Fax 85796 0
Email 85796 0
julie.fleet@unisa.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


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.