Clinical Trial: Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

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 Summary: 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.
Sponsor: University Hospital, Lille

Current Primary Outcome: Cephalic presentation [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Successful manual external cephalic version after intervention [ Time Frame: 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 [ Time Frame: Date of delivery ]
    The rate of cephalic presentation at delivery will be described
  • Cesarean section rate [ Time Frame: Date of delivery ]
    The cesarean section rate will be described
  • Premature rupture of membranes [ Time Frame: Before delivery ]
    The rate of premature rupture of membranes will be described


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: December 5, 2011
Date Started: October 2006
Date Completion:
Last Updated: January 16, 2012
Last Verified: December 2010