NCT01487590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

4.2 years

First QC Date

December 5, 2011

Last Update Submit

November 24, 2025

Conditions

Keywords

pregnancybreechacupuncturemoxibustionversion

Outcome Measures

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.

    at 37+2 weeks of gestation

Secondary Outcomes (4)

  • Successful manual external cephalic version after intervention

    Before 41 weeks of gestation

  • Cephalic presentation at delivery

    Date of delivery

  • Cesarean section rate

    Date of delivery

  • Premature rupture of membranes

    Before delivery

Study Arms (2)

Acupuncture moxibustion

ACTIVE COMPARATOR

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

Other: Acupuncture moxibustion

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Also known as: no applicable
Acupuncture moxibustion
PlaceboOTHER

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

Also known as: no applicable
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • breech presentation,
  • SINGLETON

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Jeanne de Flandre, CHRU de Lille

Lille, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Damien SUBTIL, PhD-MD

    CHRU de Lille, France

    PRINCIPAL INVESTIGATOR
  • Capucine COULON, MD

    CHRU de Lille, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations