Breech PresentationNCT00813683
Cephalic Version by Acupuncture for Breech Presentation
A study testing Acupuncture stimulation in people with Breech Presentation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy. Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Acupuncture stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to May 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single pregnancy at 32-34 weeks of pregnancy.
- Fetus in breech presentation.
Who cannot join
- Twins.
- Story of preterm birth or any preterm birth risk
- Fetal malformations, abnormal karyotype
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie-Obstétrique, Hôpital SIHCUS - CMCO, 19 rue Louis Pasteur
Schiltigheim, 67303
About this study
Official title: Study of Cephalic Version by Acupuncture for Breech Presentation.
We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy.
Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham.
Protocol :
- Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.
- Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (sham).
- Ultrasonographic control of presentation at 35 weeks.
- Conditions
- Breech Presentation
- Being tested
- Acupuncture stimulation
- Keywords
- Acupuncture, moxybustion,, Cephalic version,, Breech presentation
- 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 stimulationOther
Acupuncture by stimulation of "67 Bladder" point
Acupuncture stimulationOther
Acupuncture stimulation of "45 Stomach" point (sham)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stimulation of "67 Bladder" point Receives: Other: Acupuncture stimulation |
| 2 | Sham comparator | Stimulation of "45 Stomach" point (sham) Receives: Other: Acupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
Measured: 35 weeks
Secondary outcomes (1)
general outcomes about external cephalic version, delivery and neonates
Measured: 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2014
- Study completionMay 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain FAVRE, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813683
- Sponsor's protocol ID
- 3993
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2008
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sananes N, Roth GE, Aissi GA, Meyer N, Bigler A, Bouschbacher JM, Helmlinger C, Viville B, Guilpain M, Gaudineau A, Akladios CY, Nisand I, Langer B, Vayssiere C, Favre R. Acupuncture version of breech presentation: a randomized sham-controlled single-blinded trial. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:24-30. doi: 10.1016/j.ejogrb.2016.07.492. Epub 2016 Aug 2.
PubMed 27521594
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cephalic Version by Acupuncture for Breech Presentation.
- ClinicalTrials.gov ID
- NCT00813683
- Acronym / sponsor ID
- 3993
- Conditions
- Breech Presentation
- Keywords
- Acupuncture, moxybustion,, Cephalic version,, Breech presentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Dec 2008 (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.
We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy.
Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham.
Protocol :
- Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.
- Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (sham).
- Ultrasonographic control of presentation at 35 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Acupuncture stimulationStimulation of "67 Bladder" point |
| 2 | Sham comparator | Other: Acupuncture stimulationStimulation of "45 Stomach" point (sham) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single pregnancy at 32-34 weeks of pregnancy.
- Fetus in breech presentation.
Key exclusion criteria (3 listed)
- Twins.
- Story of preterm birth or any preterm birth risk
- Fetal malformations, abnormal karyotype
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 stimulationAcupuncture by stimulation of "67 Bladder" point | Other | 1 |
| Acupuncture stimulationAcupuncture stimulation of "45 Stomach" point (sham) | Other | 2 |
Primary outcome
Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy)
Time frame: 35 weeks
1 secondary outcome
general outcomes about external cephalic version, delivery and neonates
Time frame: 35 weeks
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 22 Dec 2025.
- Results publication: PubMed 27521594Sananes N, Roth GE, Aissi GA, Meyer N, Bigler A, Bouschbacher JM, Helmlinger C, Viville B, Guilpain M, Gaudineau A, Akladios CY, Nisand I, Langer B, Vayssiere C, Favre R. Acupuncture version of breech presentation: a randomized sham-controlled single-blinded trial. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:24-30. doi: 10.1016/j.ejogrb.2016.07.492. Epub 2016 Aug 2.
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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.
Romain FAVRE, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 stimulation in people with Breech Presentation, run by University Hospital, Strasbourg, France 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 3 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 22 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 or breech presentation (ultrasonographic control at 35 weeks of pregnancy) (time frame: 35 weeks). 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 NCT00813683, 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 22 Dec 2025.