Presentation; Breech, With External Version Before LaborNCT02251886
Moxibustion in a Randomized Trial for Version of Breech Position From Week 32
A study testing Moxibustion in primiparae and Moxibustion in multiparae in people with Presentation; Breech, With External Version Before Labor, run by Herning Hospital.
Trial summary
Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Presentation; Breech, With External Version Before Labor
- What is being tested?
- Moxibustion in primiparae and Moxibustion in multiparae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- pregnant women with singleton breech position of their babies
Who cannot join
- vaginal bleeding in 2nd and 3rd trimester, placental insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, high blood pressure, pelvic insufficiency, low placental position, placenta praevia, uterine malformations, previous corrective uterine surgery, known fetal morbidity
About this study
Official title: Moxibustion for Version of Singleton Breech Position Before Term
Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.
Read the detailed description
Moxibustion was tested for version of a breech position in singleton pregnancies.
The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.
Sample size calculation gave 45 women in each group, based on alfa 0.05 and beta 20 under condition of a 30 % effect of moxibustion vs. 20 % of spontaneous version in the control group in primiparae and 60 % in multiparae, respectively. Thus, 4 times 45 women in each group were sought. Only women who had performed three treatments were judged under the principle of intention to treat.
Exclusion criteria at inclusion in week 32 was bleeding in 2nd and 3rd trimester, placenta insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, elevated blood pressure, pelvic insufficiency, low placental position, uterine malformations, former uterine corrective surgery and known fetal morbidity
- Being tested
- Moxibustion in primiparae, Moxibustion in multiparae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxibustion in primiparaeOther
Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Moxibustion in multiparaeOther
Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion in primiparae | Active comparator | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Receives: Other: Moxibustion in primiparae |
| Moxibustion in multiparae | Active comparator | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Receives: Other: Moxibustion in multiparae |
| Control primiparae | No intervention | No intervention. Routine control schedule for primiparae with midwife |
| Control multiparae | No intervention | No intervention. Routine control schedule for multiparae with midwife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJan 2003
- Primary completionJan 2011
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Presentation; Breech, With External Version Before LaborStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Friis Lauszus, Herning Hospital
- Investigators
- Finn F Lauszus, PhD, Principal investigator, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251886
- Sponsor's protocol ID
- Moxibustion and breech
- Status last verified
- Jan 2017
- First submitted
- 25 Sep 2014
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bue L, Lauszus FF. Moxibustion did not have an effect in a randomised clinical trial for version of breech position. Dan Med J. 2016 Feb;63(2):A5199.
PubMed 26836801
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxibustion for Version of Singleton Breech Position Before Term
- ClinicalTrials.gov ID
- NCT02251886
- Acronym / sponsor ID
- Moxibustion and breech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Posted 1 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.
Detailed description
Moxibustion was tested for version of a breech position in singleton pregnancies.
The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.
Sample size calculation gave 45 women in each group, based on alfa 0.05 and beta 20 under condition of a 30 % effect of moxibustion vs. 20 % of spontaneous version in the control group in primiparae and 60 % in multiparae, respectively. Thus, 4 times 45 women in each group were sought. Only women who had performed three treatments were judged under the principle of intention to treat.
Exclusion criteria at inclusion in week 32 was bleeding in 2nd and 3rd trimester, placenta insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, elevated blood pressure, pelvic insufficiency, low placental position, uterine malformations, former uterine corrective surgery and known fetal morbidity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moxibustion in primiparae | Active comparator | Other: Moxibustion in primiparaeMoxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae |
| Moxibustion in multiparae | Active comparator | Other: Moxibustion in multiparaeMoxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae |
| Control primiparae | No intervention | –No intervention. Routine control schedule for primiparae with midwife |
| Control multiparae | No intervention | –No intervention. Routine control schedule for multiparae with midwife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women with singleton breech position of their babies
Key exclusion criteria (1 listed)
- vaginal bleeding in 2nd and 3rd trimester, placental insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, high blood pressure, pelvic insufficiency, low placental position, placenta praevia, uterine malformations, previous corrective uterine surgery, known fetal morbidity
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 in primiparaeNumber of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment | Other | Moxibustion in primiparae |
| Moxibustion in multiparaeNumber of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment" | Other | Moxibustion in multiparae |
Primary outcome
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
Time frame: 4 weeks
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26836801Bue L, Lauszus FF. Moxibustion did not have an effect in a randomised clinical trial for version of breech position. Dan Med J. 2016 Feb;63(2):A5199.
Related trials for Presentation; Breech, With External Version Before Labor
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
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.
Finn F Lauszus, PhD principal investigator
Herning Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in primiparae and Moxibustion in multiparae in people with Presentation; Breech, With External Version Before Labor, run by Herning Hospital.
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 1 inclusion and 1 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment (time frame: 4 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 NCT02251886, 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 3 Mar 2017.