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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
  Purpose

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.


Condition Intervention
Breech Presentation
Other: Acupuncture moxibustion
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 328
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupuncture moxibustion
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
Other: Acupuncture moxibustion
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
Other Name: no applicable
Placebo Comparator: Placebo
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
Other: Placebo
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
Other Name: no applicable

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breech presentation,
  • SINGLETON

Exclusion Criteria:

  • maternal age between 18 ans 45,
  • multiple gestation,
  • fetal or uterine malformation,
  • premature rupture of membranes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487590

Locations
France
Hopital Jeanne de Flandre, CHRU de Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Damien SUBTIL, PhD-MD CHRU de Lille, France
Study Chair: Capucine COULON, MD CHRU de Lille, France
  More Information

No publications provided by University Hospital, Lille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01487590     History of Changes
Other Study ID Numbers: DGS 2006/0404
Study First Received: December 5, 2011
Last Updated: January 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
pregnancy
breech
acupuncture
moxibustion
version

Additional relevant MeSH terms:
Breech Presentation
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014