<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/NCT01708668</url>
  </required_header>
  <id_info>
    <org_study_id>NJMCHH-2012-A010</org_study_id>
    <secondary_id>08NMUM063</secondary_id>
    <secondary_id>YKK08119</secondary_id>
    <secondary_id>YKK11058</secondary_id>
    <nct_id>NCT01708668</nct_id>
  </id_info>
  <brief_title>The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia</brief_title>
  <acronym>EIEBFLA</acronym>
  <official_title>The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ShanWu Feng, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent&#xD;
      epidural injections appear to reduce the incidence of maternal intra-partum fever compared to&#xD;
      continuous epidural infusion during labor analgesia. However, the optimal combination of&#xD;
      bolus volume and administrating interval has not yet been compared. The purpose of this&#xD;
      prospective, randomized, double-blind trial was to determine how intermittent epidural bolus&#xD;
      reduced the incidence of maternal intra-partum fever compared with continuous epidural&#xD;
      infusion during labor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal oral and tympanic temperature</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal serum Interleukin-1β</measure>
    <time_frame>At time of placental delivery and 3, 6 and 12 hours later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord serum Interleukin-1β</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum Interleukin-6</measure>
    <time_frame>At time of placental delivery and 3, 6 and 12 hours later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord serum Interleukin-6</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum Interleukin-10</measure>
    <time_frame>At time of placental delivery and 3, 6 and 12 hours later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord serum Interleukin-10</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum tumor necrosis factor-α</measure>
    <time_frame>At time of placental delivery and 3, 6 and 12 hours later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord serum tumor necrosis factor-α</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regression and correlation analyses between maternal and cord serum cytokines</measure>
    <time_frame>At twelve hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental routine pathologic examination</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal and cord blood gase analysis</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal modified Bromage scale and visual analogue scale</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture</measure>
    <time_frame>At two hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cesarean delivery and instrument-assisted delivery</measure>
    <time_frame>At time of placental delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indications of cesarean delivery</measure>
    <time_frame>Initiation of analgesia to placental delivery (approximately 8 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of analgesia</measure>
    <time_frame>Initiation of analgesia to 2 h postpartum (approximately 10 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durations of labor stages</measure>
    <time_frame>From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal satisfaction with analgesia</measure>
    <time_frame>At two hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of oxytocin after analgesia</measure>
    <time_frame>At twenty-four hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low back pain at 3 months after vaginal delivery</measure>
    <time_frame>At the third month after vaginal delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding success at 6 weeks after vaginal delivery</measure>
    <time_frame>At the sixth week after successful delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Apgar scale</measure>
    <time_frame>At the first and fifth minutes after baby was born</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of maternal side effects</measure>
    <time_frame>Initiation of analgesia to 2 hour postpartum (approximately 10 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Neurologic and Adaptive Capacity Score</measure>
    <time_frame>At 30 min, 2 h, and 24 h after baby was born</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxytocin dose</measure>
    <time_frame>At twenty-four hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal sepsis evaluation</measure>
    <time_frame>At 30 min after baby was born</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal antibiotic treatment</measure>
    <time_frame>One week after baby was born</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate, respiratory rate, and blood pressure</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest thoracic sensory level to alcohol</measure>
    <time_frame>At three hours after initiation of analgesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uterine contraction</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal rectal temperature</measure>
    <time_frame>At delivery, 30 min after delivery, and 1 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal heart rate</measure>
    <time_frame>From initiation of analgesia to delivery (approximately 8 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal group B streptococcus (GBS) colonization</measure>
    <time_frame>At time of initiation of analgesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured</measure>
    <time_frame>From initiation of analgesia to delivery (approximately 8 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal weight</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha</measure>
    <time_frame>At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal postpartum depression</measure>
    <time_frame>At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Labor Pain</condition>
  <condition>Pain</condition>
  <condition>Neurologic Manifestations</condition>
  <condition>Signs and Symptoms</condition>
  <condition>Pathological Conditions, Signs and Symptoms</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural analgesia (EA) with continuous epidural infusion(CEI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural analgesia</intervention_name>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
    <arm_group_label>5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Combined spinal-epidural analgesia</intervention_name>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>6</arm_group_label>
    <arm_group_label>7</arm_group_label>
    <arm_group_label>8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous epidural infusion</intervention_name>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intermittent epidural bolus</intervention_name>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
    <arm_group_label>5</arm_group_label>
    <arm_group_label>6</arm_group_label>
    <arm_group_label>7</arm_group_label>
    <arm_group_label>8</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous women&#xD;
&#xD;
          -  Required labor analgesia&#xD;
&#xD;
          -  Chinese&#xD;
&#xD;
          -  Spontaneous labor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for epidural analgesia&#xD;
&#xD;
          -  Allergic to opioids and/or local anesthetics&#xD;
&#xD;
          -  Failed to performing epidural catheterization&#xD;
&#xD;
          -  Organic dysfunction&#xD;
&#xD;
          -  Those who were not willing to or could not finish the whole study at any time&#xD;
&#xD;
          -  Using or used in the past 14 days of the monoamine oxidase inhibitors&#xD;
&#xD;
          -  Alcohol addictive or narcotic dependent patients&#xD;
&#xD;
          -  Subjects with a nonvertex presentation or scheduled induction of labor&#xD;
&#xD;
          -  Twin gestation and breech presentation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shanwu Feng, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shanwu Feng, M.D.</last_name>
    <phone>+86 25 52226112</phone>
    <email>shanwufeng@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shanwu Feng, M.D.</last_name>
      <phone>+86 25 52226112</phone>
      <email>shanwufeng@163.com</email>
    </contact>
    <investigator>
      <last_name>Shanwu Feng, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>January 14, 2015</last_update_submitted>
  <last_update_submitted_qc>January 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>ShanWu Feng, M.D.</investigator_full_name>
    <investigator_title>Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004</investigator_title>
  </responsible_party>
  <keyword>Fever</keyword>
  <keyword>Patient controlled epidural analgesia</keyword>
  <keyword>Labor analgesia</keyword>
  <keyword>Epidural analgesia</keyword>
  <keyword>Combined spinal-epidural analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Labor Pain</mesh_term>
  </condition_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/NCT01708668
org study id: NJMCHH-2012-A010
secondary id: 08NMUM063
secondary id: YKK08119
secondary id: YKK11058
nct id: NCT01708668
lead sponsor: 
has dmc: Yes
Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent
      epidural injections appear to reduce the incidence of maternal intra-partum fever compared to
      continuous epidural infusion during labor analgesia. However, the optimal combination of
      bolus volume and administrating interval has not yet been compared. The purpose of this
      prospective, randomized, double-blind trial was to determine how intermittent epidural bolus
      reduced the incidence of maternal intra-partum fever compared with continuous epidural
      infusion during labor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Maternal oral and tympanic temperature
time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Maternal serum Interleukin-1β
time frame: At time of placental delivery and 3, 6 and 12 hours later
measure: Cord serum Interleukin-1β
time frame: At time of placental delivery
measure: Maternal serum Interleukin-6
time frame: At time of placental delivery and 3, 6 and 12 hours later
measure: Cord serum Interleukin-6
time frame: At time of placental delivery
measure: Maternal serum Interleukin-10
time frame: At time of placental delivery and 3, 6 and 12 hours later
measure: Cord serum Interleukin-10
time frame: At time of placental delivery
measure: Maternal serum tumor necrosis factor-α
time frame: At time of placental delivery and 3, 6 and 12 hours later
measure: Cord serum tumor necrosis factor-α
time frame: At time of placental delivery
measure: Regression and correlation analyses between maternal and cord serum cytokines
time frame: At twelve hours postpartum
measure: Placental routine pathologic examination
time frame: At time of placental delivery
measure: Maternal and cord blood gase analysis
time frame: At time of placental delivery
measure: Maternal modified Bromage scale and visual analogue scale
time frame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
measure: Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
time frame: At two hours postpartum
measure: Rates of cesarean delivery and instrument-assisted delivery
time frame: At time of placental delivery
measure: Indications of cesarean delivery
time frame: Initiation of analgesia to placental delivery (approximately 8 hours)
measure: Duration of analgesia
time frame: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
measure: Durations of labor stages
time frame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
measure: Maternal satisfaction with analgesia
time frame: At two hours postpartum
measure: Use of oxytocin after analgesia
time frame: At twenty-four hours postpartum
measure: Low back pain at 3 months after vaginal delivery
time frame: At the third month after vaginal delivery
measure: Breastfeeding success at 6 weeks after vaginal delivery
time frame: At the sixth week after successful delivery
measure: Neonatal Apgar scale
time frame: At the first and fifth minutes after baby was born
measure: Incidence of maternal side effects
time frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
measure: Neonatal Neurologic and Adaptive Capacity Score
time frame: At 30 min, 2 h, and 24 h after baby was born
measure: Maximal oxytocin dose
time frame: At twenty-four hours postpartum
measure: Neonatal sepsis evaluation
time frame: At 30 min after baby was born
measure: Neonatal antibiotic treatment
time frame: One week after baby was born
measure: Maternal heart rate, respiratory rate, and blood pressure
time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Highest thoracic sensory level to alcohol
time frame: At three hours after initiation of analgesia
measure: Uterine contraction
time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Neonatal rectal temperature
time frame: At delivery, 30 min after delivery, and 1 h after delivery
measure: Fetal heart rate
time frame: From initiation of analgesia to delivery (approximately 8 hours)
measure: Maternal group B streptococcus (GBS) colonization
time frame: At time of initiation of analgesia
measure: Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured
time frame: From initiation of analgesia to delivery (approximately 8 hours)
measure: Neonatal weight
time frame: At delivery
measure: Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound
time frame: At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)
measure: Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha
time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Maternal postpartum depression
time frame: At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)
arm group label: 1
arm group type: Active Comparator
description: Epidural analgesia (EA) with continuous epidural infusion(CEI)
arm group label: 2
arm group type: Active Comparator
description: Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI)
arm group label: 3
arm group type: Active Comparator
description: Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
arm group label: 4
arm group type: Active Comparator
description: Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
arm group label: 5
arm group type: Active Comparator
description: Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
arm group label: 6
arm group type: Active Comparator
description: Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes)
arm group label: 7
arm group type: Active Comparator
description: Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
arm group label: 8
arm group type: Active Comparator
description: Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes)
intervention type: Procedure
intervention name: Epidural analgesia
arm group label: 1
arm group label: 3
arm group label: 4
arm group label: 5
intervention type: Procedure
intervention name: Combined spinal-epidural analgesia
arm group label: 2
arm group label: 6
arm group label: 7
arm group label: 8
intervention type: Procedure
intervention name: Continuous epidural infusion
arm group label: 1
arm group label: 2
intervention type: Procedure
intervention name: Intermittent epidural bolus
arm group label: 3
arm group label: 4
arm group label: 5
arm group label: 6
arm group label: 7
arm group label: 8
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Shanwu Feng, M.D.
role: Study Director
affiliation: Nanjing Medical University
last name: Shanwu Feng, M.D.
phone: +86 25 52226112
email: shanwufeng@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Nanjing Medical University
investigator full name: ShanWu Feng, M.D.
investigator title: Department of Anesthesiology, Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu, China, 210004
mesh term: Neurologic Manifestations
mesh term: Labor Pain