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

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ClinicalTrials.gov Identifier: NCT02251886
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : December 1, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Finn Friis Lauszus, Herning Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Presentation; Breech, With External Version Before Labor Other: Moxibustion in primiparae Other: Moxibustion in multiparae Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Moxibustion for Version of Singleton Breech Position Before Term
Study Start Date : January 2003
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2014
Arms and Interventions
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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
 Other: Moxibustion 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
 Other: Moxibustion 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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251886


Sponsors and Collaborators
Herning Hospital
Investigators
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Principal Investigator: Finn F Lauszus, PhD Herning Hospital
More Information
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Publications of Results:

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Responsible Party: Finn Friis Lauszus, Associate Professor, Senior Consultant, Herning Hospital
ClinicalTrials.gov Identifier: NCT02251886    
Other Study ID Numbers: Moxibustion and breech
First Posted: September 29, 2014    Key Record Dates
Results First Posted: December 1, 2016
Last Update Posted: March 3, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications