None listed
Conditions
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.
Interventions
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 p
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed