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Trial registered on ANZCTR


Registration number
ACTRN12609000985280
Ethics application status
Approved
Date submitted
12/11/2009
Date registered
16/11/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Moxibustion for cephalic version: a feasibility study
Scientific title
A pilot randomised controlled trial (RCT) to determine the acceptability to randomization and to determine a sample size for an appropriately powered RCT to evaluate the effectiveness and cost effectiveness of moxibustion for cephalic version
Secondary ID [1] 252175 0
Moxibustion for breech presentation
Universal Trial Number (UTN)
Trial acronym
MCV Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetus presenting as breech 252125 0
Condition category
Condition code
Reproductive Health and Childbirth 252333 252333 0 0
Fetal medicine and complications of pregnancy
Alternative and Complementary Medicine 252334 252334 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment requires the practitioner to light the moxa sticks and hold them over the acupuncture point Bladder 67 (a point located on the lateral side of the 5th toe). The moxa sticks will be held over both feet for a total of 20 minutes. The sticks are held over the points, approximately one thumb width above the point, until the woman feels the points become uncomfortably hot. The practitioner will then remove the sticks for one or two seconds before applying them to the points again. The procedure is performed twice a day for ten days. If the woman is certain the baby has turned to a cephalic presentation she will be advised to continue with the moxa for the 10 day duration but reduce the amount of stimulation to ten minutes.
Women will continue with routine care and visits to the antanatal clinic at two weekly intervals.
Intervention code [1] 241506 0
Treatment: Other
Comparator / control treatment
Women will continue with routine care and visits to the antanatal clinic at two weekly intervals.
Control group
Active

Outcomes
Primary outcome [1] 253207 0
Cephalic presentation of the fetus at birth
Timepoint [1] 253207 0
Birth of the fetus .
Secondary outcome [1] 262136 0
Need for external cephalic version as assessed by ultrasound.
Timepoint [1] 262136 0
38 weeks gestation
Secondary outcome [2] 262137 0
Mode of birth, perinatal morbidity and mortality, and maternal complications
Timepoint [2] 262137 0
Birth of the fetus (~40 weeks)
Secondary outcome [3] 262138 0
Adverse events e.g minor discomfort, blistering, burn, and maternal satisfaction, measured by self report though a self completion questionnaire.
Timepoint [3] 262138 0
Birth of the fetus (~40 weeks)

Eligibility
Key inclusion criteria
Pregnant women, aged at least 18 years, a singleton breech presentation, normal
fetal biometry with a gestational age equal to or more than 34 weeks. An ultrasound scan will be required to confirm the type of breech presentation and the location of the placenta.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Twin pregnancy, risk of premature birth, heart or kidney disease affecting the
mother, placenta previa, a history of antepartum hemorrhage, intrauterine growth restriction, hypertensive disease, isoimmunization, previous uterine operations, uterine anomaly, prelabor
rupture of the membranes, multiple pregnancy, fetal congenital abnormality, contraindication to vaginal delivery, or fetal death in utero.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment to the trial will involve recruiting patients from the John Hunter
Hospital antenatal clinic.

Women will be allocated to a study group by taking the next sequentially numbered sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be in balanced, variable blocks, prepared by a researcher not involved with the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243977 0
University
Name [1] 243977 0
Exploring Pregnancy Outcomes Collaboration (ExPO)
Address [1] 243977 0
College of Health and Science
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith South DC NSW 1797
Country [1] 243977 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC NSW 1797
Country
Australia
Secondary sponsor category [1] 251330 0
University
Name [1] 251330 0
Centre for Complementary Medicine Research
Address [1] 251330 0
University of Western Sydney
Campbelltown Campus, Building 5
Locked Bag 1797
Penrith South DC NSW 1797
Country [1] 251330 0
Australia
Other collaborator category [1] 922 0
Hospital
Name [1] 922 0
John Hunter Hospital
Address [1] 922 0
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country [1] 922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244087 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 244087 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 244087 0
Australia
Date submitted for ethics approval [1] 244087 0
27/08/2009
Approval date [1] 244087 0
12/10/2009
Ethics approval number [1] 244087 0
EC00403

Summary
Brief summary
The aim of this project is to undertake a pilot randomised controlled trial to determine the acceptability to randomization and a sample size for an appropriately powered RCT to evaluate the effectiveness and cost effectiveness of moxibustion for cephalic version of a fetus presenting as breech. Moxibustion would be compared to standard hospital management to establish whether there is evidence of some benefit from moxibustion in a controlled setting. The rationale for this design is that it would best answer practical questions regarding the design of a future clinical trial.
Trial website
Trial related presentations / publications
Presentation will be made at conferences and a manuscript prepared for publication.
Public notes

Contacts
Principal investigator
Name 30465 0
Address 30465 0
Country 30465 0
Phone 30465 0
Fax 30465 0
Email 30465 0
Contact person for public queries
Name 13712 0
Dr Caroline Smith
Address 13712 0
Centre for Complementary Medicine Research
University of Western Sydney
Building 5, Campbelltown Campus
Locked Bag 1797
SOUTH PENRITH DC
NSW 1797
Country 13712 0
Australia
Phone 13712 0
+61 2 46203777
Fax 13712 0
+61 2 46203291
Email 13712 0
caroline.smith@uws.edu.au
Contact person for scientific queries
Name 4640 0
Dr Caroline Smith
Address 4640 0
Centre for Complementary Medicine Research
University of Western Sydney
Building 5, Campbelltown Campus
Locked Bag 1797
SOUTH PENRITH DC
NSW 1797
Country 4640 0
Australia
Phone 4640 0
+61 2 46203777
Fax 4640 0
+61 2 46203291
Email 4640 0
caroline.smith@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary