<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/NCT04504682</url>
  </required_header>
  <id_info>
    <org_study_id>IRB19-1600</org_study_id>
    <nct_id>NCT04504682</nct_id>
  </id_info>
  <brief_title>Ambulation With Labor Epidural in Obese Women</brief_title>
  <official_title>Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>
      The purpose of this study is to determine if ambulation with a labor epidural in place is&#xD;
      associated with decreased rate of cesarean delivery in obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obese women are known to have increased risk of cesarean delivery and prolonged labors. Low&#xD;
      concentration epidural analgesia can achieve pain relief and allow for ambulation. Prior&#xD;
      investigations have not shown a benefit in cesarean delivery between those who ambulate with&#xD;
      an epidural and those who do not. These studies were conducted in women with normal weights.&#xD;
      It is unknown if ambulation with a labor epidural is beneficial in decreasing cesarean&#xD;
      delivery among obese women.&#xD;
&#xD;
      Obese women at term with a singleton pregnancy will be enrolled in this pilot study. Patients&#xD;
      will receive their epidural analgesia when they desire per standard protocol at our&#xD;
      institution. Following epidural placement, a Modified Bromage Score and straight leg test&#xD;
      will be performed. If the patient passes the straight leg test and has a modified Bromage&#xD;
      score &gt; 6, they will be allowed to ambulate. They will be encouraged to ambulate for 20&#xD;
      minutes per hour with another adult alongside them. Obstetric care will be standard of care.&#xD;
&#xD;
      On postpartum day one, the patient will be administered a Labor Agentry Scale. Chart review&#xD;
      will then be conducted to review maternal and neonatal outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Limited recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The person completing analysis will be blinded to the treatment group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cesarean Delivery Rate</measure>
    <time_frame>At time of delivery</time_frame>
    <description>Percent of cesarean delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Labor Duration</measure>
    <time_frame>From labor onset to time of delivery</time_frame>
    <description>Duration (hrs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First Stage Duration</measure>
    <time_frame>From onset of labor until complete dilation</time_frame>
    <description>Duration (hrs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Second Stage Duration</measure>
    <time_frame>From complete dilation until delivery</time_frame>
    <description>Duration (hrs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Labor Control</measure>
    <time_frame>Within 4 days postpartum</time_frame>
    <description>Score on Labor Agentry Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Obesity</condition>
  <condition>Labor Onset and Length Abnormalities</condition>
  <arm_group>
    <arm_group_label>Ambulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be encouraged to ambulate with epidural in place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ambulation</intervention_name>
    <description>Patients will be encouraged to ambulate for 20 minutes of every hour.</description>
    <arm_group_label>Ambulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects capable of giving consent Singleton pregnancy Nulliparous (defined as no previous&#xD;
        pregnancy beyond 20 weeks 0 days) Gestational age greater than or equal to 37 weeks BMI &gt; =&#xD;
        35 at time of delivery admission Adult companion available Anticipated vaginal delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Physical disability precluding ambulation Magnesium Administration Contraindications to&#xD;
        neuraxial analgesia Cerclage in current pregnancy Active labor DPE Category III fetal heart&#xD;
        tracing Fetal Demise In Utero&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maritza Gonzalez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vallejo MC, Firestone LL, Mandell GL, Jaime F, Makishima S, Ramanathan S. Effect of epidural analgesia with ambulation on labor duration. Anesthesiology. 2001 Oct;95(4):857-61. doi: 10.1097/00000542-200110000-00012.</citation>
    <PMID>11605924</PMID>
  </reference>
  <reference>
    <citation>Collis RE, Harding SA, Morgan BM. Effect of maternal ambulation on labour with low-dose combined spinal-epidural analgesia. Anaesthesia. 1999 Jun;54(6):535-9. doi: 10.1046/j.1365-2044.1999.00802.x.</citation>
    <PMID>10403865</PMID>
  </reference>
  <reference>
    <citation>Karraz MA. Ambulatory epidural anesthesia and the duration of labor. Int J Gynaecol Obstet. 2003 Feb;80(2):117-22. doi: 10.1016/s0020-7292(02)00339-9.</citation>
    <PMID>12566183</PMID>
  </reference>
  <reference>
    <citation>Vahratian A, Zhang J, Troendle JF, Savitz DA, Siega-Riz AM. Maternal prepregnancy overweight and obesity and the pattern of labor progression in term nulliparous women. Obstet Gynecol. 2004 Nov;104(5 Pt 1):943-51. doi: 10.1097/01.AOG.0000142713.53197.91.</citation>
    <PMID>15516383</PMID>
  </reference>
  <reference>
    <citation>Nuthalapaty FS, Rouse DJ, Owen J. The association of maternal weight with cesarean risk, labor duration, and cervical dilation rate during labor induction. Obstet Gynecol. 2004 Mar;103(3):452-6. doi: 10.1097/01.AOG.0000102706.84063.C7. Erratum In: Obstet Gynecol. 2004 May;103(5 Pt 1):1019.</citation>
    <PMID>14990405</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_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/NCT04504682
org study id: IRB19-1600
nct id: NCT04504682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if ambulation with a labor epidural in place is
      associated with decreased rate of cesarean delivery in obese patients.
Obese women are known to have increased risk of cesarean delivery and prolonged labors. Low
      concentration epidural analgesia can achieve pain relief and allow for ambulation. Prior
      investigations have not shown a benefit in cesarean delivery between those who ambulate with
      an epidural and those who do not. These studies were conducted in women with normal weights.
      It is unknown if ambulation with a labor epidural is beneficial in decreasing cesarean
      delivery among obese women.

      Obese women at term with a singleton pregnancy will be enrolled in this pilot study. Patients
      will receive their epidural analgesia when they desire per standard protocol at our
      institution. Following epidural placement, a Modified Bromage Score and straight leg test
      will be performed. If the patient passes the straight leg test and has a modified Bromage
      score > 6, they will be allowed to ambulate. They will be encouraged to ambulate for 20
      minutes per hour with another adult alongside them. Obstetric care will be standard of care.

      On postpartum day one, the patient will be administered a Labor Agentry Scale. Chart review
      will then be conducted to review maternal and neonatal outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: The person completing analysis will be blinded to the treatment group.
measure: Cesarean Delivery Rate
time frame: At time of delivery
description: Percent of cesarean delivery
measure: Labor Duration
time frame: From labor onset to time of delivery
description: Duration (hrs)
measure: First Stage Duration
time frame: From onset of labor until complete dilation
description: Duration (hrs)
measure: Second Stage Duration
time frame: From complete dilation until delivery
description: Duration (hrs)
measure: Perceived Labor Control
time frame: Within 4 days postpartum
description: Score on Labor Agentry Scale
arm group label: Ambulation
arm group type: Experimental
description: Participants in this arm will be encouraged to ambulate with epidural in place.
intervention type: Behavioral
intervention name: Ambulation
description: Patients will be encouraged to ambulate for 20 minutes of every hour.
arm group label: Ambulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maritza Gonzalez
role: Principal Investigator
affiliation: Faculty
facility: 
country: United States
citation: Vallejo MC, Firestone LL, Mandell GL, Jaime F, Makishima S, Ramanathan S. Effect of epidural analgesia with ambulation on labor duration. Anesthesiology. 2001 Oct;95(4):857-61. doi: 10.1097/00000542-200110000-00012.
PMID: 11605924
citation: Collis RE, Harding SA, Morgan BM. Effect of maternal ambulation on labour with low-dose combined spinal-epidural analgesia. Anaesthesia. 1999 Jun;54(6):535-9. doi: 10.1046/j.1365-2044.1999.00802.x.
PMID: 10403865
citation: Karraz MA. Ambulatory epidural anesthesia and the duration of labor. Int J Gynaecol Obstet. 2003 Feb;80(2):117-22. doi: 10.1016/s0020-7292(02)00339-9.
PMID: 12566183
citation: Vahratian A, Zhang J, Troendle JF, Savitz DA, Siega-Riz AM. Maternal prepregnancy overweight and obesity and the pattern of labor progression in term nulliparous women. Obstet Gynecol. 2004 Nov;104(5 Pt 1):943-51. doi: 10.1097/01.AOG.0000142713.53197.91.
PMID: 15516383
citation: Nuthalapaty FS, Rouse DJ, Owen J. The association of maternal weight with cesarean risk, labor duration, and cervical dilation rate during labor induction. Obstet Gynecol. 2004 Mar;103(3):452-6. doi: 10.1097/01.AOG.0000102706.84063.C7. Erratum In: Obstet Gynecol. 2004 May;103(5 Pt 1):1019.
PMID: 14990405
responsible party type: Sponsor
mesh term: Congenital Abnormalities
sharing ipd: No