<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/NCT02198157</url>
  </required_header>
  <id_info>
    <org_study_id>45-14-EMC</org_study_id>
    <nct_id>NCT02198157</nct_id>
  </id_info>
  <brief_title>Urinary Catheterization and Second Stage of Labor</brief_title>
  <acronym>cath2stage</acronym>
  <official_title>Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raed Salim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Labor is divided into three stages: the first stage is from labor onset until full&#xD;
           dilation, second stage is from full dilation until delivery of the baby, and the third&#xD;
           stage from the delivery of the baby until the delivery of the placenta&#xD;
&#xD;
        -  The mean duration of second stage in nulliparas as defined by the American college of&#xD;
           obstetricians and gynecologists (ACOG) is 54 minutes&#xD;
&#xD;
        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.&#xD;
           Prolonged second stage in nullipara women with epidural is defined as more than 3 hours,&#xD;
           and more than 2 hours in those without epidural.&#xD;
&#xD;
        -  Although perinatal outcome is not compromised with a prolonged second stage , there is&#xD;
           evidence that maternal morbidities such as perineal trauma, chorioamnionitis&#xD;
           ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage&#xD;
&#xD;
        -  Another effect of epidural anesthesia during labor is urinary retention and a need for&#xD;
           catheterization.&#xD;
&#xD;
        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the&#xD;
           birth canal, increasing by that the duration of the second stage.&#xD;
&#xD;
        -  This study aims to investigate the effect of intermittent versus continuous&#xD;
           catheterization on the duration of the second stage of labor&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">May 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of second stage of labor</measure>
    <time_frame>within the first 48 hours after delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>chorioamnionitis</measure>
    <time_frame>within the first 48 hours after delivery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>post-partum hemorrhage</measure>
    <time_frame>within the first 48 hours after delivery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Labor, Second Stage</condition>
  <arm_group>
    <arm_group_label>intermittent urinary catheterization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continuous urinary catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>urinary catheterization</intervention_name>
    <description>nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.</description>
    <arm_group_label>continuous urinary catheter</arm_group_label>
    <arm_group_label>intermittent urinary catheterization</arm_group_label>
    <other_name>continuous versus intermittent catheterization.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous women&#xD;
&#xD;
          -  Gestational age 24-42 weeks&#xD;
&#xD;
          -  epidural anaesthesia&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Singleton&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>raed salim, MD</last_name>
    <role>Study Director</role>
    <affiliation>Dep. OB/GYN, HaEmek Medical Center, Afula, Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>abeer suleiman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. OB/GYN, HaEmek Medical Center, Afula, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dep. OB/GYN, HaEmek Medical Center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 20, 2016</last_update_submitted>
  <last_update_submitted_qc>February 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Raed Salim</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>duration of second stage</keyword>
  <keyword>urinary catheterization</keyword>
  <keyword>epidural anaesthesia</keyword>
  <!-- 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/NCT02198157
org study id: 45-14-EMC
nct id: NCT02198157
lead sponsor: 
has dmc: Yes
-  Labor is divided into three stages: the first stage is from labor onset until full
           dilation, second stage is from full dilation until delivery of the baby, and the third
           stage from the delivery of the baby until the delivery of the placenta

        -  The mean duration of second stage in nulliparas as defined by the American college of
           obstetricians and gynecologists (ACOG) is 54 minutes

        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.
           Prolonged second stage in nullipara women with epidural is defined as more than 3 hours,
           and more than 2 hours in those without epidural.

        -  Although perinatal outcome is not compromised with a prolonged second stage , there is
           evidence that maternal morbidities such as perineal trauma, chorioamnionitis
           ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage

        -  Another effect of epidural anesthesia during labor is urinary retention and a need for
           catheterization.

        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the
           birth canal, increasing by that the duration of the second stage.

        -  This study aims to investigate the effect of intermittent versus continuous
           catheterization on the duration of the second stage of labor
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: duration of second stage of labor
time frame: within the first 48 hours after delivery
measure: chorioamnionitis
time frame: within the first 48 hours after delivery
measure: post-partum hemorrhage
time frame: within the first 48 hours after delivery
arm group label: intermittent urinary catheterization
arm group type: Active Comparator
description: nullipara women with epidural anaesthesia who pose urination difficulty will receive intermittent catheterization
arm group label: continuous urinary catheter
arm group type: Active Comparator
description: nullipara women with epidural anaesthesia who pose urination difficulty will receive continuous catheterization
intervention type: Other
intervention name: urinary catheterization
description: nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
arm group label: continuous urinary catheter
arm group label: intermittent urinary catheterization
other name: continuous versus intermittent catheterization.
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: raed salim, MD
role: Study Director
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
last name: abeer suleiman, MD
role: Principal Investigator
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
facility: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Raed Salim
investigator title: MD