Skip to main content
OpenTrials
Completed

NCT Number: NCT02251886

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxibustion in primiparae

Other

Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment

Moxibustion in multiparae

Other

Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"

Primary outcomes

  1. Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment

    Time frame: 4 weeks

    Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Registry information

Official study title

Moxibustion for Version of Singleton Breech Position Before Term

Important dates

Study start
2003
Primary completion
2011
Study completion
2014
First posted
Sep 29, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.