OBJECTIVES:Moxibustion, a Traditional Chinese Medicine technique related to acupuncture, was proposed to facilitate cephalic version of breech presentation. Several trials were conducted to evaluate the efficacy, but there are few reports on the safety of moxibustion. Our objective was to assess the side-effects and acceptability of this intervention. DESIGN: We are conducting a randomized controlled trial to evaluate the efficacy of moxibustion for breech version. The first 12 participants randomized in the moxibustion group had additional fetal surveillance by electronic monitoring. SUBJECTS:Pregnant women with a fetus in breech presentation are included in the trial between 34 and 36 weeks of gestation. INTERVENTIONS: We performed a cardiotocogram during 10 minutes before, 20 minutes during, and 10 minutes after each session. A maximum of 9 sessions were scheduled every other day, and stopped when cephalic version was diagnosed. The recordings were assessed by 3 independent readers using the Fischer scoring system. OUTCOME MEASURES: Fetal well-being was evaluated by the cardiotocogram; effect on the mother was evaluated by blood pressure recorded before and after each session; maternal views, contractions, and perceived changes in fetal movements were assessed using a questionnaire. RESULTS: A total of 65 cardiotocograms were analyzed. All scores were considered as normal, being at 8 or more on a 0-10 scale. Acceptability for the women and compliance to the intervention were good. No significant maternal or fetal side-effect was observed. CONCLUSIONS: We have not detected alterations of fetal and maternal well-being or other side-effects associated with moxibustion applied to the BL 67 for cephalic version of breech presentations. Moxibustion appears to be safe for both the mother and the fetus.
RCT Entities:
OBJECTIVES: Moxibustion, a Traditional Chinese Medicine technique related to acupuncture, was proposed to facilitate cephalic version of breech presentation. Several trials were conducted to evaluate the efficacy, but there are few reports on the safety of moxibustion. Our objective was to assess the side-effects and acceptability of this intervention. DESIGN: We are conducting a randomized controlled trial to evaluate the efficacy of moxibustion for breech version. The first 12 participants randomized in the moxibustion group had additional fetal surveillance by electronic monitoring. SUBJECTS: Pregnant women with a fetus in breech presentation are included in the trial between 34 and 36 weeks of gestation. INTERVENTIONS: We performed a cardiotocogram during 10 minutes before, 20 minutes during, and 10 minutes after each session. A maximum of 9 sessions were scheduled every other day, and stopped when cephalic version was diagnosed. The recordings were assessed by 3 independent readers using the Fischer scoring system. OUTCOME MEASURES: Fetal well-being was evaluated by the cardiotocogram; effect on the mother was evaluated by blood pressure recorded before and after each session; maternal views, contractions, and perceived changes in fetal movements were assessed using a questionnaire. RESULTS: A total of 65 cardiotocograms were analyzed. All scores were considered as normal, being at 8 or more on a 0-10 scale. Acceptability for the women and compliance to the intervention were good. No significant maternal or fetal side-effect was observed. CONCLUSIONS: We have not detected alterations of fetal and maternal well-being or other side-effects associated with moxibustion applied to the BL 67 for cephalic version of breech presentations. Moxibustion appears to be safe for both the mother and the fetus.