<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/NCT01686347</url>
  </required_header>
  <id_info>
    <org_study_id>2010/146/HP</org_study_id>
    <nct_id>NCT01686347</nct_id>
  </id_info>
  <brief_title>Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil</brief_title>
  <acronym>epidarc</acronym>
  <official_title>Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the investigators study is to demonstrate the association between fetal cardiac&#xD;
      rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine&#xD;
      and/or sufentanil.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate</measure>
    <time_frame>1 day</time_frame>
    <description>Maternal Plasmatic concentrations of ropivacaine will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate</measure>
    <time_frame>1 day</time_frame>
    <description>Maternal Plasmatic concentrations of sufentanil will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Fetal Cardiac Rhythm Abnormalities</condition>
  <arm_group>
    <arm_group_label>fetal cardiac rhythm abnormally</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ropivacaine</intervention_name>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>fetal cardiac rhythm abnormally</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or more&#xD;
&#xD;
          -  nulliparous&#xD;
&#xD;
             _ one fetus&#xD;
&#xD;
          -  head first&#xD;
&#xD;
          -  spontaneous labor&#xD;
&#xD;
          -  epidural analgesia&#xD;
&#xD;
          -  no fetal cardiac rhythm abnormalies before the epidural analgesia&#xD;
&#xD;
          -  no active management of labor during 30 minutes after the epidural analgesia induction&#xD;
&#xD;
          -  at term&#xD;
&#xD;
          -  signature of the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pathological pregnancy&#xD;
&#xD;
          -  low maternal blood pressure during the 30 minutes after the epidural analgesia&#xD;
&#xD;
          -  uterin contraction which last for 5 minutes or more&#xD;
&#xD;
          -  more than 6 uterin contractions during a 10 minutes period&#xD;
&#xD;
          -  Ropivacaine contraindication&#xD;
&#xD;
          -  sufentanil contraindication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>centre hospitalier universitaire de Rouen, Hopital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>June 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epidural analgesia</keyword>
  <keyword>fetal cardiac rythm</keyword>
  <keyword>ropivacaine</keyword>
  <keyword>sufentanil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01686347
org study id: 2010/146/HP
nct id: NCT01686347
lead sponsor: 
has dmc: No
The aim of the investigators study is to demonstrate the association between fetal cardiac
      rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine
      and/or sufentanil.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
time frame: 1 day
description: Maternal Plasmatic concentrations of ropivacaine will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test
measure: Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
time frame: 1 day
description: Maternal Plasmatic concentrations of sufentanil will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test
arm group label: fetal cardiac rhythm abnormally
arm group type: Other
description: patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
arm group label: control group
arm group type: Other
description: patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
intervention type: Drug
intervention name: ropivacaine
arm group label: control group
arm group label: fetal cardiac rhythm abnormally
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Congenital Abnormalities
mesh term: Ropivacaine