<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/NCT02212210</url>
  </required_header>
  <id_info>
    <org_study_id>Goodier_Epidural_Steroids</org_study_id>
    <nct_id>NCT02212210</nct_id>
  </id_info>
  <brief_title>Maternal Epidural Steroids and Hyperthemia</brief_title>
  <official_title>Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to look to see if adding steroids to an epidural reduces the&#xD;
      chances of having a fever in labor, and protects the baby from exposure to inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The association between epidural analgesia and increased maternal intrapartum temperature has&#xD;
      been well documented in multiple randomized controlled trials. The exact mechanism for this&#xD;
      elevation in temperature is unknown; however the most likely cause appears to be&#xD;
      non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been&#xD;
      linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer&#xD;
      length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may&#xD;
      lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy.&#xD;
      The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1%&#xD;
      to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is&#xD;
    closed&#xD;
  </why_stopped>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Early Phase 1</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of maternal fever</measure>
    <time_frame>delivery</time_frame>
    <description>Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of funisitis</measure>
    <time_frame>delivery</time_frame>
    <description>Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>IL-6 level</measure>
    <time_frame>delivery</time_frame>
    <description>Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Fever</condition>
  <condition>Labor Pain</condition>
  <condition>Complication of Anesthesia During Pregnancy, Unspecified</condition>
  <arm_group>
    <arm_group_label>Methylprednisolone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2cc preservative free normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <arm_group_label>Methylprednisolone</arm_group_label>
    <other_name>DEPO-MEDROL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
    <other_name>Saline placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Nulliparity&#xD;
&#xD;
          -  Age&gt;=18&#xD;
&#xD;
          -  Patient requests epidural analgesia&#xD;
&#xD;
          -  GA &gt;= 37 weeks&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  No prenatal care&#xD;
&#xD;
          -  Temperature &gt;99.4 at decision for epidural placement&#xD;
&#xD;
          -  Cervical dilation &gt;4cm&#xD;
&#xD;
          -  Diabetes (pre-gestational or gestational)&#xD;
&#xD;
          -  Autoimmune condition&#xD;
&#xD;
          -  Pre-eclampsia&#xD;
&#xD;
          -  Maternal heart disease&#xD;
&#xD;
          -  Current steroid use&#xD;
&#xD;
          -  Active infection (bacterial or viral)&#xD;
&#xD;
          -  Wet Tap (CSF on placement of epidural)&#xD;
&#xD;
          -  Pre-gestational diabetes&#xD;
&#xD;
          -  Known systemic infection (bacterial, viral, fungal or tubercular)&#xD;
&#xD;
          -  Known allergy to steroids&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  Hypertensive crisis&#xD;
&#xD;
          -  History of active epilepsy&#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>Christopher G Goodier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Christopher G. Goodier</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <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>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</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/NCT02212210
org study id: Goodier_Epidural_Steroids
nct id: NCT02212210
lead sponsor: 
has dmc: Yes
The purpose of this study is to look to see if adding steroids to an epidural reduces the
      chances of having a fever in labor, and protects the baby from exposure to inflammation.
The association between epidural analgesia and increased maternal intrapartum temperature has
      been well documented in multiple randomized controlled trials. The exact mechanism for this
      elevation in temperature is unknown; however the most likely cause appears to be
      non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been
      linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer
      length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may
      lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy.
      The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1%
      to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rate of maternal fever
time frame: delivery
description: Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
measure: Rate of funisitis
time frame: delivery
description: Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.
measure: IL-6 level
time frame: delivery
description: Cord blood will be obtained at delivery and plasma will be assessed for IL-^ levels by standard ELISA.
arm group label: Methylprednisolone
arm group type: Active Comparator
description: 1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline
arm group label: Normal saline
arm group type: Placebo Comparator
description: 2cc preservative free normal saline
intervention type: Drug
intervention name: Methylprednisolone
arm group label: Methylprednisolone
other name: DEPO-MEDROL
intervention type: Drug
intervention name: Normal saline
arm group label: Normal saline
other name: Saline placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher G Goodier, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Christopher G. Goodier
investigator title: Instructor
mesh term: Labor Pain
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate