Breech Presentation
Conditions
Keywords
pregnancy, breech, acupuncture, moxibustion, version
Brief summary
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
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.
Interventions
OTHERAcupuncture moxibustion
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
OTHERPlacebo
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* breech presentation, * SINGLETON
Exclusion criteria
* maternal age between 18 ans 45, * multiple gestation, * fetal or uterine malformation, * premature rupture of membranes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cephalic presentation | at 37+2 weeks of gestation | Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean section rate | Date of delivery | The cesarean section rate will be described |
| Premature rupture of membranes | Before delivery | The rate of premature rupture of membranes will be described |
| Cephalic presentation at delivery | Date of delivery | The rate of cephalic presentation at delivery will be described |
| Successful manual external cephalic version after intervention | Before 41 weeks of gestation | In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied. |
Countries
France
Outcome results
None listed