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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture moxibustion | Active Comparator | Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. |
|
| Placebo | Placebo Comparator | Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture moxibustion | Other | Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien SUBTIL, PhD-MD | CHRU de Lille, France | Principal Investigator |
| Capucine COULON, MD | CHRU de Lille, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Jeanne de Flandre, CHRU de Lille | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24901279 | Result | Coulon C, Poleszczuk M, Paty-Montaigne MH, Gascard C, Gay C, Houfflin-Debarge V, Subtil D. Version of breech fetuses by moxibustion with acupuncture: a randomized controlled trial. Obstet Gynecol. 2014 Jul;124(1):32-39. doi: 10.1097/AOG.0000000000000303. |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Other | Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart |
|
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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 |