Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001126909
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
27/10/2011
Date last updated
20/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Complementary Medicine techniques for Labour and Birth: A Mixed Methods Study.
Scientific title
For primiparous women, does an antenatal package of complementary medicine techniques for labour and birth, plus standard care, reduce rates of epidural use when compared with standard care alone? A mixed methods study.
Secondary ID [1] 273156 0
Nil
Universal Trial Number (UTN)
U1111-1125-0022
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidural use in primiparous women 278905 0
Birth satisfaction 278906 0
Medical interventions in labour 278907 0
Condition category
Condition code
Reproductive Health and Childbirth 279086 279086 0 0
Childbirth and postnatal care
Public Health 279244 279244 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a two-day workshop, held at the study hospital over a weekend, which occurs once per month for a period of 10 months. Study particpants and their birth partners will attend 1 weekend course during the period of 24-34 weeks of gestation. The workshop will introduce 6 different complementary medicine techniques for labour and birth: Education - the hormones of labour, and the fear-tension-pain cycle; breathing techniques; guided visualisation; acupressure; movement/yoga techniques; facilitation of partner support and its current evidence. The workshop will introduce 3 concepts each day of the weekend, which will run for for 6 hours each day. The intervention will be conducted by the researcher, Kate Levett, who is a qualified teacher (BEd), Researcher (MPH), Childbirth Educator (She Births), Acupuncturist (Adv.Dip.App.Sci.Acup, and Grad.Cert.Jap.Acup.).
The intervention group will also be advised and encouraged to attend the hospital based antenatal education classes (standard care), which is run by Midwifery Educators at each of the study hospitals.
Intervention code [1] 269490 0
Prevention
Comparator / control treatment
Standard care, which is the hospital based antenatal education classes. These classes are run by Midwifery Educators employed by the hospital to run these classes. The hospital schedules these classes regularly with options for weekend courses, or weeknight courses depending on the preference of the participants.
Control group
Active

Outcomes
Primary outcome [1] 279727 0
20% reduction in rate of epidural use. This outcome will be collected from the Maternity Unit's discharge summary sheet, which is included in the individual medical records of the participants. The use of epidural anaesthesia will be indicated by its selection in a computer generator form which is completed by midwives at the time of discharge of the patient from hospital following the birth of their baby.
Timepoint [1] 279727 0
At birth of child, less than 20 weeks following randomisation
Secondary outcome [1] 294314 0
Medical interventions in labour. These will ascertained from the Maternity Unit's Discharge Summary Sheet, which is included in the individual medical records of the participants. The notation of medical intervention will be indicated by its selection in a computer generator form which is completed by midwives at the time of discharge of the patient from hospital following the birth of their baby.
This will include: induction of labour; failed induction of labour; augmentation of labour; instrumental delivery; episiotomy; caesarean section (CS); emergency or planned CS; length of labour; gestational age at delivery; length of stay in hospital.
Timepoint [1] 294314 0
At birth of child, less than 20 weeks following randomisation
Secondary outcome [2] 294315 0
Birth satisfaction as measured by the Labour Agentry Scale (Hodnett, 1987)
Timepoint [2] 294315 0
Pre Intervention, post-intervention and post-labour/birth. All will occur less than 20 weeks following randomisation.

Eligibility
Key inclusion criteria
Primiparous women, 24-36 weeks of gestation, low-risk normal pregnancy, cephalic presentation, sufficient English to participate in a 2-day workshop.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High risk pregnancy, multiparous, any congenital abnormalities, Participation in similar programme of complementary antenatal education, Participation in a midwifery model of care, insufficient English for participation, non-consent.

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)
Primiparous women will be approached in antenatal clinics at the two study hospitals. They will be confirmed as having a low risk pregnancy, and given information regarding the trial. If they wish to participate, they will be randomised to the study group or the control group via an online randomisation service, 'sealedenvelope.com'. Allocation will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will occur from the online randomisation service.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
mixed methods study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4657 0
2044

Funding & Sponsors
Funding source category [1] 284101 0
University
Name [1] 284101 0
University of Western Sydney
Country [1] 284101 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
CompleMed
Building 5,
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 269063 0
None
Name [1] 269063 0
Address [1] 269063 0
Country [1] 269063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272051 0
Northern Sydney Central Coast Area Health Service
Ethics committee address [1] 272051 0
Research Office
Level 2, Building 51,
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 272051 0
Australia
Date submitted for ethics approval [1] 272051 0
05/11/2011
Approval date [1] 272051 0
Ethics approval number [1] 272051 0

Summary
Brief summary
We have chosen two established antenatal education programmes (‘SheBirths’ and 'Acubirth'), which together introduce 6 different CM techniques for the management of labour and birth. We plan to introduce the programme via 10 two-day workshop to 96 women and their birth partners over a period of 12 months. We will adapt the programme for implementation at 2 large teaching hospitals in NSW. Participants and their birth partners will be recruited from Antenatal clinics from 24 weeks of gestation and randomly allocated to attend the CM birth education program plus standard care or to standard care alone. The CM birth education programme is an intervention which introduces techniques of: Physiology of birth, the Fear-Pain-Tension cycle; Movement and positions for birth; Acupressure techniques; Guided visualisation; Breathing techniques.
Outcomes: The primary outcome to be evaluated is the rate of epidural use. Secondary outcomes to be evaluated include: pharmacological pain relief, instrumental delivery; caesarean section; length of labour; Apgar scores; admission to NICU/SCN; gestational age at delivery; satisfaction/control scores and post-natal depression scores.
Trial website
http://www.uws.edu.au/complemed
Trial related presentations / publications
Presentations: Poster presentation at the Integrative Medicine Forum on 22 & 23 Oct 2011
Poster presentation at the Research Futures Postgraduates Forum 8, 9 & 10 June 2011
Public notes

Contacts
Principal investigator
Name 33230 0
Address 33230 0
Country 33230 0
Phone 33230 0
Fax 33230 0
Email 33230 0
Contact person for public queries
Name 16477 0
Kate Levett
Address 16477 0
Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Australia
Country 16477 0
Australia
Phone 16477 0
+61 2 4620 3284
Fax 16477 0
+61 2 4620 3291
Email 16477 0
17164519@student.uws.edu.au
Contact person for scientific queries
Name 7405 0
A/Prof Caroline Smith
Address 7405 0
Centre for Complementary Medicine Research
LG, Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Australia
Country 7405 0
Australia
Phone 7405 0
+61 2 4620 3284
Fax 7405 0
+61 2 4620 3291
Email 7405 0
C.Smith@uws.edu.au

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

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