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Open Access Study protocol

Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice

Jorge Vas1*, José Manuel Aranda2, Mercedes Barón3, Emilio Perea-Milla4, Camila Méndez5, Carmen Ramírez6, Inmaculada Aguilar1, Manuela Modesto1, Ana María Lara7, Francisco Martos8 and Antonio J García-Ruiz8

Author Affiliations

1 Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain

2 San Andrés-Torcal Primary Healthcare Centre, Málaga, Spain

3 El Lugar Primary Healthcare Centre, Chiclana de la Frontera, Spain

4 Support Research Unit (Network and Cooperative Research Centres of Epidemiology. CIBERESP), Costa del Sol Hospital, Marbella, Spain

5 Andalusian Public Health System, Sevilla, Spain

6 Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain

7 Gonzalo Bilbao, Primary Healthcare Centre, Sevilla, Spain

8 Department of Pharmacology, Malaga University, Spain

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BMC Complementary and Alternative Medicine 2008, 8:22  doi:10.1186/1472-6882-8-22

Published: 21 May 2008

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/Design

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.

Discussion

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.

Trial registration

Current Controlled Trials ISRCTN10634508.