Moxibustion in a Randomized Trial for Version of Breech Position From Week 32
Primary Purpose
Presentation; Breech, With External Version Before Labor
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moxibustion in primiparae
Moxibustion in multiparae
Sponsored by
About this trial
This is an interventional treatment trial for Presentation; Breech, With External Version Before Labor
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
No Intervention
No Intervention
Arm Label
Moxibustion in primiparae
Moxibustion in multiparae
Control primiparae
Control multiparae
Arm Description
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
No intervention. Routine control schedule for primiparae with midwife
No intervention. Routine control schedule for multiparae with midwife
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02251886
Brief Title
Moxibustion in a Randomized Trial for Version of Breech Position From Week 32
Official Title
Moxibustion for Version of Singleton Breech Position Before Term
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herning Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presentation; Breech, With External Version Before Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxibustion in primiparae
Arm Type
Active Comparator
Arm Description
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Arm Title
Moxibustion in multiparae
Arm Type
Active Comparator
Arm Description
Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Arm Title
Control primiparae
Arm Type
No Intervention
Arm Description
No intervention. Routine control schedule for primiparae with midwife
Arm Title
Control multiparae
Arm Type
No Intervention
Arm Description
No intervention. Routine control schedule for multiparae with midwife
Intervention Type
Other
Intervention Name(s)
Moxibustion in primiparae
Intervention Description
Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Intervention Type
Other
Intervention Name(s)
Moxibustion in multiparae
Intervention Description
Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
Primary Outcome Measure Information:
Title
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
Description
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn F Lauszus, PhD
Organizational Affiliation
Herning Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26836801
Citation
Bue L, Lauszus FF. Moxibustion did not have an effect in a randomised clinical trial for version of breech position. Dan Med J. 2016 Feb;63(2):A5199.
Results Reference
result
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Moxibustion in a Randomized Trial for Version of Breech Position From Week 32
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