<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/NCT03018171</url>
  </required_header>
  <id_info>
    <org_study_id>01.17</org_study_id>
    <nct_id>NCT03018171</nct_id>
  </id_info>
  <brief_title>Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor</brief_title>
  <acronym>ICA</acronym>
  <official_title>Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Giovanni Calibita Fatebenefratelli Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Giovanni Calibita Fatebenefratelli Hospital</source>
  <brief_summary>
    <textblock>
      The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in&#xD;
      combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor&#xD;
      performance and on maternal fetal well-being.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 4</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>local anesthetic consumption reduction</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">268</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine</intervention_name>
    <description>Intrathecal clonidine addiction</description>
    <arm_group_label>SC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>Intrathecal</description>
    <arm_group_label>S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written maternal informed consent&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age ≥ 37 weeks,&#xD;
&#xD;
          -  ASA I&#xD;
&#xD;
          -  BMI &lt; 30&#xD;
&#xD;
          -  fetus in cephalic presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspect or certainty of fetal malformation,&#xD;
&#xD;
          -  Presence of conditions such as preeclampsia, multiparity, preterm labor&#xD;
&#xD;
          -  History of adverse reaction to α-2 adrenergic agonists&#xD;
&#xD;
          -  Nicotine addiction&#xD;
&#xD;
          -  Chronic use of opioid&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Claroni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fatebenefratelli San Giovanni Calibita - Tiberine Island</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Grazia Frigo, MD</last_name>
    <phone>+39066837258</phone>
    <email>mariagrazia.frigo@fbf-isola.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00186</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Aversano, MD</last_name>
      <phone>+39066837258</phone>
      <email>m.aversano@me.com</email>
    </contact>
    <investigator>
      <last_name>Claudia Claroni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clonidine, spinal injections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clonidine</mesh_term>
    <mesh_term>Sufentanil</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/NCT03018171
org study id: 01.17
nct id: NCT03018171
lead sponsor: 
The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in
      combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor
      performance and on maternal fetal well-being.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: local anesthetic consumption reduction
time frame: 8 months
arm group label: SC
arm group type: Experimental
description: this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor
arm group label: S
arm group type: Active Comparator
description: this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor
intervention type: Drug
intervention name: Clonidine
description: Intrathecal clonidine addiction
arm group label: SC
intervention type: Drug
intervention name: Sufentanil
description: Intrathecal
arm group label: S
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Claudia Claroni, MD
role: Principal Investigator
affiliation: Fatebenefratelli San Giovanni Calibita - Tiberine Island
last name: Maria Grazia Frigo, MD
phone: +39066837258
email: mariagrazia.frigo@fbf-isola.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Labor Pain
mesh term: Clonidine
mesh term: Sufentanil