Breech PresentationPhase 3NCT00890474
Moxibustion for Fetus in Breech Presentation
A Phase 3 study testing Moxibustion of the BL67 acupoint in people with Breech Presentation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version. Design: Randomised controlled trial Setting: University hospital. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Moxibustion of the BL67 acupoint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Jan 2009
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breech presentation
- 34 to 36 weeks of gestation
- Single fetus
Who cannot join
- Uterine malformation
- Placenta praevia
- Transverse lie
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version.
Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106).
Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.
- Conditions
- Breech Presentation
- Being tested
- Moxibustion of the BL67 acupoint
- Keywords
- Breech presentation at 34 to 36 weeks of gestation
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxibustion of the BL67 acupointProcedure or surgery
Moxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | Not described Receives: Procedure: Moxibustion of the BL67 acupoint |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic presentation at delivery or before external cephalic version
Measured: end of pregnancy
Secondary outcomes (3)
Mode of delivery
Measured: end of pregnancy
Women's views on the intervention
Measured: end of pregnancy
External cephalic version
Measured: end of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startOct 2004
- Primary completionDec 2008
- Study completionJan 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Loterie Romande
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890474
- Sponsor's protocol ID
- Moxibustion_siege
- Status last verified
- Apr 2009
- First submitted
- 28 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M. Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):1034-1040. doi: 10.1097/AOG.0b013e3181bc707a.
PubMed 20168104
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxibustion for Fetus in Breech Presentation
- ClinicalTrials.gov ID
- NCT00890474
- Acronym / sponsor ID
- Moxibustion_siege
- Conditions
- Breech Presentation
- Keywords
- Breech presentation at 34 to 36 weeks of gestation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Loterie Romande
- Study start
- Oct 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Apr 2009 (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.
Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version.
Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106).
Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Procedure: Moxibustion of the BL67 acupoint |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Breech presentation
- 34 to 36 weeks of gestation
- Single fetus
Key exclusion criteria (3 listed)
- Uterine malformation
- Placenta praevia
- Transverse lie
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 |
|---|---|---|
| Moxibustion of the BL67 acupointMoxibustion sessions every day (every other day in hospital, self-administration at home the other day) during a maximum of 14 days. Stopped if cephalic version. | Procedure or surgery | Moxibustion |
Primary outcome
Cephalic presentation at delivery or before external cephalic version
Time frame: end of pregnancy
3 secondary outcomes
Mode of delivery
Time frame: end of pregnancy
Women's views on the intervention
Time frame: end of pregnancy
External cephalic version
Time frame: end of pregnancy
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 29 Apr 2009.
- Derived from this study: PubMed 20168104Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M. Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):1034-1040. doi: 10.1097/AOG.0b013e3181bc707a.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxibustion of the BL67 acupoint in people with Breech Presentation, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 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 29 Apr 2009. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 at delivery or before external cephalic version (time frame: end of pregnancy). 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 NCT00890474, 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 29 Apr 2009.