search
Back to results

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
Herning Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presentation; Breech, With External Version Before Labor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    September 25, 2014
    Last Updated
    January 18, 2017
    Sponsor
    Herning Hospital
    search

    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

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs