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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxibustion in primiparae | Other | Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finn F Lauszus, PhD | Herning Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26836801 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxibustion in Primiparae | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae |
| FG001 | Moxibustion in Multiparae | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae |
| FG002 | Control Primiparae | No intervention. Routine control schedule for primiparae with midwife |
| FG003 | Control Multiparae | No intervention. Routine control schedule for multiparae with midwife |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxibustion in Primiparae | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae |
| BG001 | Moxibustion in Multiparae |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxibustion in Primiparae | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Finn Lauszus | Herning Hospital | +45 78434614 | finlau@rm.dk |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Moxibustion in multiparae | Other | Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment" |
|
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae |
| BG002 | Control Primiparae | No intervention. Routine control schedule for primiparae with midwife |
| BG003 | Control Multiparae | No intervention. Routine control schedule for multiparae with midwife |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Gestational age | Mean | Standard Deviation | days |
|
| OG002 | Control Primiparae | No intervention. Routine control schedule for primiparae with midwife |
| OG003 | Control Multiparae | No intervention. Routine control schedule for multiparae with midwife |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Moxibustion in Multiparae | Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae | 0 | 54 | 0 | 54 |
| EG002 | Control Primiparae | No intervention. Routine control schedule for primiparae with midwife | 0 | 44 | 0 | 44 |
| EG003 | Control Multiparae | No intervention. Routine control schedule for multiparae with midwife | 0 | 54 | 0 | 54 |
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