- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251886
Moxibustion in a Randomized Trial for Version of Breech Position From Week 32
Moxibustion for Version of Singleton Breech Position Before Term
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Moxibustion in primiparae
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
|
Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
|
Active Comparator: Moxibustion in multiparae
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
|
Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
|
No Intervention: Control primiparae
No intervention.
Routine control schedule for primiparae with midwife
|
|
No Intervention: Control multiparae
No intervention.
Routine control schedule for multiparae with midwife
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Finn F Lauszus, PhD, Herning Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moxibustion and breech
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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