Breech PresentationACUVERSENCT01487590
Cephalic Version by Acupuncture-Moxibustion for Breech Presentation
A study testing Acupuncture moxibustion in people with Breech Presentation, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Acupuncture moxibustion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breech presentation,
- SINGLETON
Who cannot join
- maternal age between 18 ans 45,
- multiple gestation,
- fetal or uterine malformation,
- premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Breech Presentation
- Being tested
- Acupuncture moxibustion, Placebo
- Keywords
- pregnancy, breech, acupuncture, moxibustion, version
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture moxibustionOther
Also called no applicable
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
PlaceboOther
Also called no applicable
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture moxibustion | Active comparator | Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. Receives: Other: Acupuncture moxibustion |
| Placebo | Placebo comparator | Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 37+2 weeks of gestation
Secondary outcomes (4)
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.
Measured: Before 41 weeks of gestation
Cephalic presentation at delivery
The rate of cephalic presentation at delivery will be described
Measured: Date of delivery
Cesarean section rate
The cesarean section rate will be described
Measured: Date of delivery
Premature rupture of membranes
The rate of premature rupture of membranes will be described
Measured: Before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien SUBTIL, PhD-MD, Principal investigator, CHRU de Lille, FranceCapucine COULON, MD, Study chair, CHRU de Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487590
- Sponsor's protocol ID
- DGS 2006/0404
- Acronym
- ACUVERSE
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2011
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation
- ClinicalTrials.gov ID
- NCT01487590
- Acronym / sponsor ID
- ACUVERSE / DGS 2006/0404
- Conditions
- Breech Presentation
- Keywords
- pregnancy, breech, acupuncture, moxibustion, version
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture moxibustion | Active comparator | Other: Acupuncture moxibustionSix interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. |
| Placebo | Placebo comparator | Other: PlaceboSix interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- breech presentation,
- SINGLETON
Key exclusion criteria (4 listed)
- maternal age between 18 ans 45,
- multiple gestation,
- fetal or uterine malformation,
- premature rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture moxibustionAlso: no applicableSix interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart. | Other | Acupuncture moxibustion |
| PlaceboAlso: no applicableSix interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Successful manual external cephalic version after intervention
Time frame: Before 41 weeks of gestation
Cephalic presentation at delivery
Time frame: Date of delivery
Cesarean section rate
Time frame: Date of delivery
Premature rupture of membranes
Time frame: Before delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Results publication: PubMed 24901279Coulon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien SUBTIL, PhD-MD principal investigator
CHRU de Lille, France
Capucine COULON, MD study chair
CHRU de Lille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture moxibustion in people with Breech Presentation, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cephalic presentation (time frame: at 37+2 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.