Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

Study Overview
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Brief Summary
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For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

Detailed Description
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Monocentric controlled randomized trial in a simple blind fashion, comparing acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation between 33+5 to 35+5 weeks of gestation. The intervention arm consists of acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two days apart. In the placebo group, the cold light of an inactivated laser is to be applied in the same point during the same time. When cephalic version fail, a manual external cephalic version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of gestation.

Official Title
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A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

Conditions
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Breech Presentation

Intervention / Treatment
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* Other: Acupuncture moxibustion
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breech presentation, SINGLETON Exclusion Criteria: maternal age between 18 ans 45, multiple gestation, fetal or uterine malformation, premature rupture of membranes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture moxibustion<br>Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. | Other: Acupuncture moxibustion<br>* Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.<br>* Other names: no applicable;|
| Placebo Comparator: Placebo<br>Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart | Other: Placebo<br>* Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart<br>* Other names: no applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalic presentation | Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt. | at 37+2 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful manual external cephalic version after intervention | In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied. | Before 41 weeks of gestation | 
| Cephalic presentation at delivery | The rate of cephalic presentation at delivery will be described | Date of delivery | 
| Cesarean section rate | The cesarean section rate will be described | Date of delivery | 
| Premature rupture of membranes | The rate of premature rupture of membranes will be described | Before delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, breech, acupuncture, moxibustion, version