title: Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice.
abstract: BACKGROUND
  Non cephalic presentation in childbirth involves various risks to both the mother and the foetus. The incidence in Spain is 3.8% of all full-term pregnancies. The most common technique used to end the gestation in cases of non cephalic presentation is that of caesarian section, and although it provokes a lower rate of morbi-mortality than does vaginal delivery in such situations, there remains the possibility of traumatic injury to the foetal head and neck, while maternal morbidity is also increased. The application of heat (moxibustion) to an acupuncture point, in order to correct non cephalic presentation, has been practised in China since ancient times, but as yet there is insufficient evidence of its real effectiveness.
  
  
  METHODS
  The experimental design consists of a multi-centre randomised controlled trial with three parallel arms, used to compare real moxibustion, sham moxibustion and the natural course of events, among pregnant women with a non cephalic presentation and a gestational duration of 33-35 weeks (estimated by echography). The participants in the trial will be blinded to both interventions. The results obtained will be analyzed by professionals, blinded with respect to the allocation to the different types of intervention. In addition, we intend to carry out a economic analysis.
  
  
  CONCLUSIONS
  This trial will contribute to the development of evidence concerning moxibustion in the correction of non cephalic presentations. The primary outcome variable is the proportion of cephalic presentations at term. As secondary outcomes, we will evaluate the proportion of cephalic presentations at week 38 of gestation, determined by echography, together with the safety of the technique, the specificity of moxibustion and the control of the blinding process. This study has been funded by the Health Ministry of the Andalusian Regional Government.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10634508.
authors.affiliation: Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. jorgef.vas.sspa@juntadeandalucia.es
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Aranda
authors.forename: Mercedes
authors.initials: M
authors.lastname: Barón
authors.forename: Emilio
authors.initials: E
authors.lastname: Perea-Milla
authors.forename: Camila
authors.initials: C
authors.lastname: Méndez
authors.forename: Carmen
authors.initials: C
authors.lastname: Ramírez
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.forename: Manuela
authors.initials: M
authors.lastname: Modesto
authors.forename: Ana María
authors.initials: AM
authors.lastname: Lara
authors.forename: Francisco
authors.initials: F
authors.lastname: Martos
authors.forename: Antonio J
authors.initials: AJ
authors.lastname: García-Ruiz
mesh_terms: D000328:Adult; D001946:Breech Presentation / Q000628:therapy*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D009071:Moxibustion / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013030:Spain; D014710:Version, Fetal / Q000379:methods*