Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

Not Applicable

Completed

• Conditions: Breech Presentation
• Interventions: Other: Acupuncture moxibustion; Other: Placebo

• Registration Number: NCT01487590
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 328

Inclusion Criteria

• breech presentation,
• SINGLETON

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture moxibustion	Acupuncture moxibustion	Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
Placebo	Placebo	Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Cephalic presentation at delivery	Date of delivery	The rate of cephalic presentation at delivery will be described
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

Trial Locations

Locations (1)

Hopital Jeanne de Flandre, CHRU de Lille; 🇫🇷 Lille, France