Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

NCT ID: NCT01487590

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-12-31

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.

Conditions

Breech Presentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Acupuncture moxibustion

Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.

Group Type: ACTIVE_COMPARATOR

Acupuncture moxibustion

Intervention Type: OTHER

Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.

Placebo

Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Interventions

Acupuncture moxibustion

Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.

Intervention Type: OTHER

Placebo

Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Intervention Type: OTHER

Other Intervention Names

no applicable; no applicable

Eligibility Criteria

Inclusion Criteria

• breech presentation,
• SINGLETON

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien SUBTIL, PhD-MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Lille, France

Capucine COULON, MD

Role: STUDY_CHAIR

CHRU de Lille, France

Locations

Hopital Jeanne de Flandre, CHRU de Lille

Lille, , France

Countries

France

References

Coulon C, Poleszczuk M, Paty-Montaigne MH, Gascard C, Gay C, Houfflin-Debarge V, Subtil D. Version of breech fetuses by moxibustion with acupuncture: a randomized controlled trial. Obstet Gynecol. 2014 Jul;124(1):32-39. doi: 10.1097/AOG.0000000000000303.

Reference Type: RESULT

PMID: 24901279 (View on PubMed)

Other Identifiers

DGS 2006/0404

Identifier Type: -

Identifier Source: org_study_id