Cephalic Version by Acupuncture-Moxibustion for Breech Presentation (ACUVERSE)

University Hospital, Lille

Status: Completed

Conditions: Breech Presentation

Treatments: Other: Acupuncture moxibustion; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01487590

DGS 2006/0404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• breech presentation,
• SINGLETON

Exclusion criteria

• maternal age between 18 ans 45,
• multiple gestation,
• fetal or uterine malformation,
• premature rupture of membranes

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 2 patient groups, including a placebo group

Acupuncture moxibustion

Active Comparator group

Description:

Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.

Treatment:

Other: Acupuncture moxibustion

Placebo

Placebo Comparator group

Description:

Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Treatment:

Other: Placebo