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

Presentation; Breech, With External Version Before Labor Clinical Trial

Official title:

Moxibustion for Version of Singleton Breech Position Before Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251886
• Other study ID #: Moxibustion and breech
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: September 26, 2014
• Start date: January 2003
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: September 2014
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• Moxibustion in primiparae
Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae
• Moxibustion in multiparae
Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Version of fetal breech position to cephalic position	Moxibustion added to acupuncture point Bl 67 daily for 15-20 minutes, version occuring within the four weeks of treatment	4 weeks	No