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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01487590
First received: December 5, 2011
Last updated: January 16, 2012
Last verified: December 2010
History of Changes

December 5, 2011
January 16, 2012
October 2006
December 2010   (final data collection date for primary outcome measure)
Cephalic presentation [ Time Frame: at 37+2 weeks of gestation ] [ Designated as safety issue: No ]
Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt.
Same as current
Complete list of historical versions of study NCT01487590 on ClinicalTrials.gov Archive Site
  • Successful manual external cephalic version after intervention [ Time Frame: Before 41 weeks of gestation ] [ Designated as safety issue: No ]
    In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied.
  • Cephalic presentation at delivery [ Time Frame: Date of delivery ] [ Designated as safety issue: No ]
    The rate of cephalic presentation at delivery will be described
  • Cesarean section rate [ Time Frame: Date of delivery ] [ Designated as safety issue: No ]
    The cesarean section rate will be described
  • Premature rupture of membranes [ Time Frame: Before delivery ] [ Designated as safety issue: Yes ]
    The rate of premature rupture of membranes will be described
Same as current
Not Provided
Not Provided
 
Cephalic Version by Acupuncture-Moxibustion for Breech Presentation
A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Breech Presentation
  • Other: Acupuncture moxibustion
    Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
    Other Name: no applicable
  • Other: Placebo
    Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
    Other Name: no applicable
  • Active Comparator: Acupuncture moxibustion
    Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
    Intervention: Other: Acupuncture moxibustion
  • Placebo Comparator: Placebo
    Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • breech presentation,
  • SINGLETON

Exclusion Criteria:

  • maternal age between 18 ans 45,
  • multiple gestation,
  • fetal or uterine malformation,
  • premature rupture of membranes
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01487590
DGS 2006/0404
No
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Damien SUBTIL, PhD-MD CHRU de Lille, France
Study Chair: Capucine COULON, MD CHRU de Lille, France
University Hospital, Lille
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP