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

Not Applicable

Completed

• Conditions: Presentation; Breech, With External Version Before Labor

• Registration Number: NCT02251886
• Lead Sponsor: Herning Hospital

Brief 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. 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 Timeline

• Study Start: 2003-01
• Primary Completion: 2011-01
• Study Completion: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-29
• Results First Submitted: 2016-08-15
• Results First Submitted QC: 2016-10-10
• Results First Posted: 2016-12-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment	4 weeks	Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment