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

January 16, 2012 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Jeanne de Flandre, CHRU de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breech presentation,
  • SINGLETON

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • no applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 37+2 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before 41 weeks of gestation
Cephalic presentation at delivery
Time Frame: Date of delivery
The rate of cephalic presentation at delivery will be described
Date of delivery
Cesarean section rate
Time Frame: Date of delivery
The cesarean section rate will be described
Date of delivery
Premature rupture of membranes
Time Frame: Before delivery
The rate of premature rupture of membranes will be described
Before delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Damien SUBTIL, PhD-MD, CHRU de Lille, France
  • Study Chair: Capucine COULON, MD, CHRU de Lille, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (ESTIMATE)

December 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2006/0404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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