<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02251886</url>
  </required_header>
  <id_info>
    <org_study_id>Moxibustion and breech</org_study_id>
    <nct_id>NCT02251886</nct_id>
  </id_info>
  <brief_title>Moxibustion in a Randomized Trial for Version of Breech Position From Week 32</brief_title>
  <official_title>Moxibustion for Version of Singleton Breech Position Before Term</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herning Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herning Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Moxibustion was tested for version of a breech position in singleton pregnancies. The women&#xD;
      were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20&#xD;
      minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic&#xD;
      version was offered for those still in breech position. The randomization was stratified for&#xD;
      primigravida and multiparae separately. The randomization was made with a random number even&#xD;
      and odd numbers indicating moxibustion or not. The randomization result was hidden in a&#xD;
      sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave&#xD;
      informed consent to the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Moxibustion was tested for version of a breech position in singleton pregnancies.&#xD;
&#xD;
      The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily&#xD;
      in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external&#xD;
      cephalic version was offered for those still in breech position. The randomization was&#xD;
      stratified for primigravida and multiparae separately. The randomization was made with a&#xD;
      random number even and odd numbers indicating moxibustion or not. The randomization result&#xD;
      was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when&#xD;
      the woman gave informed consent to the study.&#xD;
&#xD;
      Sample size calculation gave 45 women in each group, based on alfa 0.05 and beta 20 under&#xD;
      condition of a 30 % effect of moxibustion vs. 20 % of spontaneous version in the control&#xD;
      group in primiparae and 60 % in multiparae, respectively. Thus, 4 times 45 women in each&#xD;
      group were sought. Only women who had performed three treatments were judged under the&#xD;
      principle of intention to treat.&#xD;
&#xD;
      Exclusion criteria at inclusion in week 32 was bleeding in 2nd and 3rd trimester, placenta&#xD;
      insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, elevated&#xD;
      blood pressure, pelvic insufficiency, low placental position, uterine malformations, former&#xD;
      uterine corrective surgery and known fetal morbidity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Presentation; Breech, With External Version Before Labor</condition>
  <arm_group>
    <arm_group_label>Moxibustion in primiparae</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxibustion in multiparae</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control primiparae</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. Routine control schedule for primiparae with midwife</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control multiparae</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. Routine control schedule for multiparae with midwife</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moxibustion in primiparae</intervention_name>
    <description>Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment</description>
    <arm_group_label>Moxibustion in primiparae</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moxibustion in multiparae</intervention_name>
    <description>Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment&quot;</description>
    <arm_group_label>Moxibustion in multiparae</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women with singleton breech position of their babies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vaginal bleeding in 2nd and 3rd trimester, placental insufficiency, cervical&#xD;
             shortening, premature rupture of membranes, preeclampsia, high blood pressure, pelvic&#xD;
             insufficiency, low placental position, placenta praevia, uterine malformations,&#xD;
             previous corrective uterine surgery, known fetal morbidity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Finn F Lauszus, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Herning Hospital</affiliation>
  </overall_official>
  <results_reference>
    <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.</citation>
    <PMID>26836801</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>August 15, 2016</results_first_submitted>
  <results_first_submitted_qc>October 10, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2016</results_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herning Hospital</investigator_affiliation>
    <investigator_full_name>Finn Friis Lauszus</investigator_full_name>
    <investigator_title>Associate Professor, Senior Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breech Presentation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Moxibustion in Primiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae&#xD;
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="P2">
          <title>Moxibustion in Multiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae&#xD;
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="P3">
          <title>Control Primiparae</title>
          <description>No intervention. Routine control schedule for primiparae with midwife</description>
        </group>
        <group group_id="P4">
          <title>Control Multiparae</title>
          <description>No intervention. Routine control schedule for multiparae with midwife</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Moxibustion in Primiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae&#xD;
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="B2">
          <title>Moxibustion in Multiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae&#xD;
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="B3">
          <title>Control Primiparae</title>
          <description>No intervention. Routine control schedule for primiparae with midwife</description>
        </group>
        <group group_id="B4">
          <title>Control Multiparae</title>
          <description>No intervention. Routine control schedule for multiparae with midwife</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="48"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="54"/>
            <count group_id="B5" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="4"/>
                    <measurement group_id="B2" value="31" spread="3"/>
                    <measurement group_id="B3" value="29" spread="4"/>
                    <measurement group_id="B4" value="31" spread="3"/>
                    <measurement group_id="B5" value="30" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="14"/>
                    <measurement group_id="B2" value="78" spread="14"/>
                    <measurement group_id="B3" value="75" spread="12"/>
                    <measurement group_id="B4" value="74" spread="15"/>
                    <measurement group_id="B5" value="76" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="229" spread="6"/>
                    <measurement group_id="B2" value="230" spread="6"/>
                    <measurement group_id="B3" value="230" spread="7"/>
                    <measurement group_id="B4" value="231" spread="7"/>
                    <measurement group_id="B5" value="230" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment</title>
        <description>Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Moxibustion in Primiparae</title>
            <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae&#xD;
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
          </group>
          <group group_id="O2">
            <title>Moxibustion in Multiparae</title>
            <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae&#xD;
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
          </group>
          <group group_id="O3">
            <title>Control Primiparae</title>
            <description>No intervention. Routine control schedule for primiparae with midwife</description>
          </group>
          <group group_id="O4">
            <title>Control Multiparae</title>
            <description>No intervention. Routine control schedule for multiparae with midwife</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment</title>
          <description>Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="34"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.48</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Moxibustion in Primiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae&#xD;
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="E2">
          <title>Moxibustion in Multiparae</title>
          <description>Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae&#xD;
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae</description>
        </group>
        <group group_id="E3">
          <title>Control Primiparae</title>
          <description>No intervention. Routine control schedule for primiparae with midwife</description>
        </group>
        <group group_id="E4">
          <title>Control Multiparae</title>
          <description>No intervention. Routine control schedule for multiparae with midwife</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Finn Lauszus</name_or_title>
      <organization>Herning Hospital</organization>
      <phone>+45 78434614</phone>
      <email>finlau@rm.dk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02251886
org study id: Moxibustion and breech
nct id: NCT02251886
lead sponsor: 
has dmc: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
time frame: 4 weeks
description: Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
arm group label: Moxibustion in primiparae
arm group type: Active Comparator
description: Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
arm group label: Moxibustion in multiparae
arm group type: Active Comparator
description: Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
arm group label: Control primiparae
arm group type: No Intervention
description: No intervention. Routine control schedule for primiparae with midwife
arm group label: Control multiparae
arm group type: No Intervention
description: No intervention. Routine control schedule for multiparae with midwife
intervention type: Other
intervention name: Moxibustion in primiparae
description: Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
arm group label: Moxibustion in primiparae
intervention type: Other
intervention name: Moxibustion in multiparae
description: Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
arm group label: Moxibustion in multiparae
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Finn F Lauszus, PhD
role: Principal Investigator
affiliation: Herning Hospital
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.
PMID: 26836801
responsible party type: Principal Investigator
investigator affiliation: Herning Hospital
investigator full name: Finn Friis Lauszus
investigator title: Associate Professor, Senior Consultant
mesh term: Breech Presentation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 