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

Jorge Vas1, José Manuel Aranda, Mercedes Barón

  • 1Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. jorgef.vas.sspa@juntadeandalucia.es

BMC Complementary and Alternative Medicine
|May 23, 2008
PubMed
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This study investigates moxibustion for correcting non-cephalic fetal presentation. It aims to provide evidence on the effectiveness and safety of this traditional Chinese medicine technique in improving birth outcomes.

Area of Science:

  • Obstetrics and Gynecology
  • Traditional Chinese Medicine
  • Clinical Trials

Background:

  • Non-cephalic presentation complicates 3.8% of Spanish term pregnancies.
  • Cesarean section is common but carries risks like fetal injury and increased maternal morbidity.
  • Moxibustion, a heat application to acupuncture points, is an ancient Chinese practice for correcting non-cephalic presentation, yet its efficacy lacks robust evidence.

Purpose of the Study:

  • To evaluate the effectiveness of moxibustion in correcting non-cephalic fetal presentation.
  • To assess the safety and efficacy of moxibustion compared to sham moxibustion and natural course.
  • To contribute evidence for clinical decision-making in managing non-cephalic presentations.

Main Methods:

  • Multi-center randomized controlled trial with three parallel arms: real moxibustion, sham moxibustion, and natural course.

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  • Inclusion criteria: pregnant women with non-cephalic presentation at 33-35 weeks gestation.
  • Blinded participants and outcome assessors; includes economic analysis.

    • Main Results:

    • Primary outcome: proportion of cephalic presentations at term.
    • Secondary outcomes: cephalic presentation at week 38, safety, moxibustion specificity, and blinding integrity.
    • Analysis will be performed by blinded professionals.

    Conclusions:

    • The trial will generate crucial evidence on moxibustion for non-cephalic presentation correction.
    • Findings will inform obstetric practice regarding the use of moxibustion.
    • Study funded by the Health Ministry of the Andalusian Regional Government.