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CompletedNCT01487590ACUVERSEUpdated Dec 2, 2025

Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

An interventional study of Acupuncture moxibustion and Placebo in Breech Presentation, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breech Presentation

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Keywords

  • pregnancy
  • breech
  • acupuncture
  • moxibustion
  • version
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • breech presentation,
  • SINGLETON

Exclusion criteria

Exclusion Criteria:

  • maternal age between 18 ans 45,
  • multiple gestation,
  • fetal or uterine malformation,
  • premature rupture of membranes
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
328 participants (actual)

Study arms

  • Active comparator
    Acupuncture moxibustion

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

    Other: Acupuncture moxibustion

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherAcupuncture moxibustion

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

    Also known as: no applicable

  • OtherPlacebo

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

    Also known as: no applicable

05

What researchers measure

Primary outcomes

  1. Cephalic presentation

    Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt.

    Time frame: at 37+2 weeks of gestation

Secondary outcomes

  1. Successful manual external cephalic version after intervention

    In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied.

    Time frame: Before 41 weeks of gestation

  2. Cephalic presentation at delivery

    The rate of cephalic presentation at delivery will be described

    Time frame: Date of delivery

  3. Cesarean section rate

    The cesarean section rate will be described

    Time frame: Date of delivery

  4. Premature rupture of membranes

    The rate of premature rupture of membranes will be described

    Time frame: Before delivery

06

Study locations

1 site
  • Hopital Jeanne de Flandre, CHRU de Lille
    Lille, France
07

References and documents

Publications

  • 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. PubMed 24901279 ↗
08

Registry details

Key details

Study ID
NCT01487590
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Dec 7, 2011
Start date
Oct 2006
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 2, 2025

Study contacts

Damien SUBTIL, PhD-MD
principal investigator · CHRU de Lille, France
Capucine COULON, MD
study chair · CHRU de Lille, France

Oversight

Data monitoring committee
No
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