An interventional study of Moxibustion in primiparae and Moxibustion in multiparae in Presentation; Breech, With External Version Before Labor, sponsored by Herning Hospital. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Herning Hospital · Not applicable, Interventional, and Treatment
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
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 200 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
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Exclusion Criteria:
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Other: Moxibustion in primiparae
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Other: Moxibustion in multiparae
No intervention. Routine control schedule for primiparae with midwife
No intervention. Routine control schedule for multiparae with midwife
Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Time frame: 4 weeks
| Milestone | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae |
|---|---|---|---|---|
| Started | 48 | 54 | 44 | 54 |
| Completed | 48 | 54 | 44 | 54 |
| Not completed | 0 | 0 | 0 | 0 |
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
| participants | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae |
|---|---|---|---|---|
| Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 34 | 25 | 34 | 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxibustion in Primiparae | — | 0/48 (0%) | 0/48 (0%) |
| Moxibustion in Multiparae | — | 0/54 (0%) | 0/54 (0%) |
| Control Primiparae | — | 0/44 (0%) | 0/44 (0%) |
| Control Multiparae | — | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 54 | 44 | 54 | 200 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| Mean | 28 ± 4 | 31 ± 3 | 29 ± 4 | 31 ± 3 | 30 ± 4 |
| Gender(Participants) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| Female | 48 | 54 | 44 | 54 | 200 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| Denmark | 48 | 54 | 44 | 54 | 200 |
| Weight(kg) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| Mean | 76 ± 14 | 78 ± 14 | 75 ± 12 | 74 ± 15 | 76 ± 14 |
| Gestational age(days) | Moxibustion in Primiparae | Moxibustion in Multiparae | Control Primiparae | Control Multiparae | Total |
|---|---|---|---|---|---|
| Mean | 229 ± 6 | 230 ± 6 | 230 ± 7 | 231 ± 7 | 230 ± 6 |
No study locations are listed for this record.
The record gives a start of Jan 2003, a primary completion of Jan 2011 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2016, 5 years 11 months after primary completion.
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Herning Hospital