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

Herning Hospital

Status: Completed

Conditions: Presentation; Breech, With External Version Before Labor

Treatments: Other: Moxibustion in multiparae; Other: Moxibustion in primiparae

Study type: Interventional

Funder types: Other

Identifiers

NCT02251886

Moxibustion and breech

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 4 patient groups

Moxibustion in primiparae

Active Comparator group

Description:

Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae

Treatment:

Other: Moxibustion in primiparae

Moxibustion in multiparae

Active Comparator group

Description:

Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae

Treatment:

Other: Moxibustion in multiparae

Control primiparae

No Intervention group

Description:

No intervention. Routine control schedule for primiparae with midwife

Control multiparae

No Intervention group

Description:

No intervention. Routine control schedule for multiparae with midwife