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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
328
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
Hopital Jeanne de Flandre, CHRU de Lille
Lille, France
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.
Time frame: at 37+2 weeks of gestation
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.
Time frame: Before 41 weeks of gestation
Cephalic presentation at delivery
The rate of cephalic presentation at delivery will be described
Time frame: Date of delivery
Cesarean section rate
The cesarean section rate will be described
Time frame: Date of delivery
Premature rupture of membranes
The rate of premature rupture of membranes will be described
Time frame: Before delivery
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