Moxibustion in a Randomized Trial for Version of Breech Position From Week 32

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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

Official Title
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Moxibustion for Version of Singleton Breech Position Before Term

Conditions
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Presentation; Breech, With External Version Before Labor

Intervention / Treatment
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* Other: Moxibustion in primiparae
* Other: Moxibustion in multiparae


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women with singleton breech position of their babies Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxibustion in primiparae<br>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae | Other: Moxibustion in primiparae<br>* Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment<br>|
| Active Comparator: Moxibustion in multiparae<br>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae | Other: Moxibustion in multiparae<br>* Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment<br>|
| No Intervention: Control primiparae<br>No intervention. Routine control schedule for primiparae with midwife | |
| No Intervention: Control multiparae<br>No intervention. Routine control schedule for multiparae with midwife | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |