<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/NCT03797833</url>
  </required_header>
  <id_info>
    <org_study_id>2018/634</org_study_id>
    <nct_id>NCT03797833</nct_id>
  </id_info>
  <brief_title>Spinal Anesthesia for External Cephalic Version</brief_title>
  <official_title>Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers&#xD;
      scheduled for external version of babies in breech position.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fetuses in breech position are almost always delivered by Caesarian section (CS). If the&#xD;
      fetus is in breech position by the end of pregnancy, attempts for external cephalic version&#xD;
      (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in&#xD;
      multiparous women. There are studies showing a higher rate of successful ECV's if the mother&#xD;
      received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with&#xD;
      SA. These studies, however, did not take parity into account.&#xD;
&#xD;
      The primary aim of this study is to see if SA can increase the rate of successful ECV's in&#xD;
      nulliparous women.&#xD;
&#xD;
      The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS&#xD;
      is decreasing using SA during ECV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Slow inclusion rate. Central contact person quit for another job.&#xD;
  </why_stopped>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2029</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>External version success rate</measure>
    <time_frame>1 hour</time_frame>
    <description>Rate of successful version as assessed by gynaecologist after maximum three attempts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall maternal satisfaction post external version attempt</measure>
    <time_frame>1 hour</time_frame>
    <description>Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall maternal satisfaction post partum</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caesarian section rate</measure>
    <time_frame>1 months</time_frame>
    <description>The mode of delivery, assessed from the medical charts after delivery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breech Presentation; Before Labor</condition>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>ECV according to standard practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal anaesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Anaesthesia</intervention_name>
    <description>Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg</description>
    <arm_group_label>Spinal anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant nulliparous women.&#xD;
&#xD;
          -  Breech presentation of fetus, eligible for external version.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate.&#xD;
&#xD;
          -  Unable to understand written and oral Swedish in the absence of interpreter.&#xD;
&#xD;
          -  Contraindications to spinal anaesthesia.&#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>Andreas Herbst, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skåne University Hospital</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skåne University Hospital</name>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.</citation>
    <PMID>25962611</PMID>
  </reference>
  <reference>
    <citation>Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27. Erratum In: Am J Obstet Gynecol. 2017 Mar;216(3):315.</citation>
    <PMID>27131581</PMID>
  </reference>
  <reference>
    <citation>Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.</citation>
    <PMID>25674710</PMID>
  </reference>
  <reference>
    <citation>Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.</citation>
    <PMID>28723831</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breech presentation, external version, spinal anaesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breech Presentation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03797833
org study id: 2018/634
nct id: NCT03797833
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers
      scheduled for external version of babies in breech position.
Fetuses in breech position are almost always delivered by Caesarian section (CS). If the
      fetus is in breech position by the end of pregnancy, attempts for external cephalic version
      (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in
      multiparous women. There are studies showing a higher rate of successful ECV's if the mother
      received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with
      SA. These studies, however, did not take parity into account.

      The primary aim of this study is to see if SA can increase the rate of successful ECV's in
      nulliparous women.

      The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS
      is decreasing using SA during ECV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: External version success rate
time frame: 1 hour
description: Rate of successful version as assessed by gynaecologist after maximum three attempts.
measure: Overall maternal satisfaction post external version attempt
time frame: 1 hour
description: Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.
measure: Overall maternal satisfaction post partum
time frame: 3 months
description: Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)
measure: Caesarian section rate
time frame: 1 months
description: The mode of delivery, assessed from the medical charts after delivery.
arm group label: Standard treatment
arm group type: No Intervention
description: ECV according to standard practice.
arm group label: Spinal anaesthesia
arm group type: Active Comparator
description: ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)
intervention type: Procedure
intervention name: Spinal Anaesthesia
description: Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg
arm group label: Spinal anaesthesia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Herbst, MD PhD
role: Principal Investigator
affiliation: Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden
facility: 
facility: 
country: Sweden
citation: Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.
PMID: 25962611
citation: Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27. Erratum In: Am J Obstet Gynecol. 2017 Mar;216(3):315.
PMID: 27131581
citation: Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.
PMID: 25674710
citation: Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.
PMID: 28723831
responsible party type: Sponsor
mesh term: Breech Presentation
mesh term: Anesthetics
sharing ipd: Undecided