<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/NCT02264834</url>
  </required_header>
  <id_info>
    <org_study_id>PDB001</org_study_id>
    <nct_id>NCT02264834</nct_id>
  </id_info>
  <brief_title>Deambulatory Epidural During the Labour</brief_title>
  <official_title>Comparison of Two Different Peridural During the Labor and Effect of Deambulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Madeleine Wilwerth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the&#xD;
      concentration of local anesthetic and therefore the motor block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized and double-blind study performed on primiparous parturient divided&#xD;
      into two distinct groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">March 20, 2018</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time between peridural application and childbirth</measure>
    <time_frame>at delivery</time_frame>
    <description>This will be used to assess labor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caesarian</measure>
    <time_frame>at delivery</time_frame>
    <description>This will be used to assess labor. Was a caesarian necessary (yes-no) ?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Instrumentalisation</measure>
    <time_frame>at delivery</time_frame>
    <description>This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apgar score of the baby</measure>
    <time_frame>at delivery</time_frame>
    <description>Evaluation of the baby, using the Apgar score. This will be used to assess labor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bromage score</measure>
    <time_frame>1h after the start of the peridural</time_frame>
    <description>Modified Bromage score (Breen et al) &gt;5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Romberg test</measure>
    <time_frame>1h after the start of the peridural</time_frame>
    <description>Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial tension</measure>
    <time_frame>1h after the start of the peridural</time_frame>
    <description>Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>First Pregnancy</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ambulatory group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0.1% + Sufentanil 0.2µg/ml</intervention_name>
    <description>Levobupivacaine 0.1% + Sufentanil 0.2µg/ml</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>control group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0.07% + Sufentanil 0.3µg/ml</intervention_name>
    <description>Levobupivacaine 0.07% + Sufentanil 0.3µg/ml</description>
    <arm_group_label>Ambulatory group</arm_group_label>
    <other_name>ambulatory group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar epidural analgesia</intervention_name>
    <description>Introduction of a catheter in lumbar epidural space</description>
    <arm_group_label>Ambulatory group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
    <other_name>labor analgesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Free written consent.&#xD;
&#xD;
          -  ASA I or II,&#xD;
&#xD;
          -  Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation&#xD;
             between 3-6 cm&#xD;
&#xD;
          -  VAS&gt; 30 mm&#xD;
&#xD;
          -  No contraindications to peridural&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Twin pregnancy, less than 36 weeks and 42 weeks&#xD;
&#xD;
          -  Fetus in breech position&#xD;
&#xD;
          -  Analgesia and sedation within 6h&#xD;
&#xD;
          -  Contraindications to peridural&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Vanderlinden</last_name>
    <role>Study Director</role>
    <affiliation>CHUB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUB</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Madeleine Wilwerth</investigator_full_name>
    <investigator_title>primary investigator</investigator_title>
  </responsible_party>
  <keyword>epidural</keyword>
  <keyword>primiparous patient</keyword>
  <keyword>deambulation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Dsuvia</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02264834
org study id: PDB001
nct id: NCT02264834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the
      concentration of local anesthetic and therefore the motor block.
Prospective, randomized and double-blind study performed on primiparous parturient divided
      into two distinct groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Time between peridural application and childbirth
time frame: at delivery
description: This will be used to assess labor.
measure: Caesarian
time frame: at delivery
description: This will be used to assess labor. Was a caesarian necessary (yes-no) ?
measure: Instrumentalisation
time frame: at delivery
description: This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?
measure: Apgar score of the baby
time frame: at delivery
description: Evaluation of the baby, using the Apgar score. This will be used to assess labor.
measure: Bromage score
time frame: 1h after the start of the peridural
description: Modified Bromage score (Breen et al) >5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity).
measure: Romberg test
time frame: 1h after the start of the peridural
description: Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).
measure: Arterial tension
time frame: 1h after the start of the peridural
description: Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).
arm group label: Control group
arm group type: Active Comparator
description: Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL
arm group label: Ambulatory group
arm group type: Experimental
description: Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL
intervention type: Drug
intervention name: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
description: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
arm group label: Control group
other name: control group
intervention type: Drug
intervention name: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
description: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
arm group label: Ambulatory group
other name: ambulatory group
intervention type: Procedure
intervention name: Lumbar epidural analgesia
description: Introduction of a catheter in lumbar epidural space
arm group label: Ambulatory group
arm group label: Control group
other name: labor analgesia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Vanderlinden
role: Study Director
affiliation: CHUB
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Dr Madeleine Wilwerth
investigator title: primary investigator
mesh term: Sufentanil
mesh term: Dsuvia
mesh term: Levobupivacaine
sharing ipd: No