Presentation; Breech, With External Version Before Labor Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment