<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/NCT02210598</url>
  </required_header>
  <id_info>
    <org_study_id>HS-13-00740</org_study_id>
    <nct_id>NCT02210598</nct_id>
  </id_info>
  <brief_title>Outpatient Labor Induction With the Transcervical Foley Balloon</brief_title>
  <official_title>Outpatient Labor Induction With the Transcervical Foley Balloon: A Randomized Trial Comparing Outpatient Immediate Removal Foley Versus Standard Inpatient Foley Induction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study represents the first randomized trial comparing traditional inpatient induction&#xD;
      with a transcervical foley catheter versus outpatient induction with immediate removal of a&#xD;
      transcervical foley catheter. The immediate removal technique allows the induction process to&#xD;
      begin in the hospital setting, but allows the patient to go home without a foreign body in&#xD;
      situ. The investigators hypothesize the outpatient group will spend less time hospitalized&#xD;
      prior to discharge. Additionally, the investigators will explore the vaginal delivery rates&#xD;
      and maternal/neonatal safety profiles between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial.&#xD;
&#xD;
      Patients who are candidates for labor induction and meet inclusion criteria will be&#xD;
      identified in the obstetrics clinic when they are being scheduled for induction of labor, or&#xD;
      at a later clinic date. If they agree to participate, patients will be randomized and&#xD;
      enrolled in the study at that time. Those who consent will be randomized into Group A&#xD;
      (Experimental Group) and Group B (Control Group). No stratification criteria will be used.&#xD;
&#xD;
      Patients randomized to the control group will undergo induction of labor using the standard&#xD;
      foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position,&#xD;
      an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL&#xD;
      of sterile saline. One of two methods will be used to place the transcervical foley based on&#xD;
      provider preference and determination of which method will offer the greatest chance for&#xD;
      successful placement. Method A is placement of the foley &quot;blindly&quot; by palpation of the&#xD;
      cervix. Method B utilizes direct visualization with sterile speculum placement. Method will&#xD;
      be documented in the data collection forms. The catheter will be left in place and IV&#xD;
      oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if&#xD;
      not spontaneously extruded.&#xD;
&#xD;
      Patients randomized to the experimental group will undergo outpatient induction of labor.&#xD;
      Either of the above two described methods will be used to place an 18 French Foley catheter&#xD;
      transcervically and its balloon filled with 60mL of sterile saline. The catheter will be&#xD;
      deflated and removed within 10 minutes of placement. The patient will then undergo a&#xD;
      non-stress test (NST). If the patient has a reactive NST with no late or variable&#xD;
      decelerations or uterine tachysystole, the patient will be discharged home with clear return&#xD;
      precautions and instructions to return to the triage area in 24 hours. When the patient&#xD;
      returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The&#xD;
      patient will then be admitted to L&amp;D for inpatient continuation of induction with IV oxytocin&#xD;
      per protocol.&#xD;
&#xD;
      In accordance with the Friedman curve and current LAC+USC practice, primigravid participants&#xD;
      will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and&#xD;
      multigravid participants will be given 14 hours before a failed induction is diagnosed.&#xD;
      Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any&#xD;
      obstetric indication as decided by the on-duty house staff. Finally, at patient request,&#xD;
      intravenous or regional anesthesia will be made available at any time during the labor and&#xD;
      delivery process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">January 2018</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 inpatient hospitalization (hours)</measure>
    <time_frame>time from hospital admission to time to discharge, on average 96 hours</time_frame>
    <description>compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of labor induction (hours)</measure>
    <time_frame>time of initiation of labor induction to delivery, on average 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cesarean section rate (percentage)</measure>
    <time_frame>determined at time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of oxytocin use during labor induction (hours)</measure>
    <time_frame>time of initiation of oxytocin until it is discontinued, on average 18 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)</measure>
    <time_frame>from initiation of labor induction to delivery, on average 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients developing chorioamnionitis during labor induction (percentage)</measure>
    <time_frame>from initiation of induction until delivery, on average 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients developing uterine tachysystole during labor induction (percentage)</measure>
    <time_frame>from initiation of labor induction to delivery, on average 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of infants admitted to NICU (percentage)</measure>
    <time_frame>on average during the 24 hours following delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>at 1 minute, 5 minutes, and 10 minutes after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Pregnancy</condition>
  <condition>Labor; Forced or Induced, Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>inpatient Foley balloon induction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley &quot;blindly&quot; by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>outpatient Foley balloon induction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&amp;D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>inpatient Foley balloon induction</intervention_name>
    <description>The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.</description>
    <arm_group_label>inpatient Foley balloon induction</arm_group_label>
    <other_name>18-French Bard catheter</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>outpatient Foley balloon induction</intervention_name>
    <description>The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.</description>
    <arm_group_label>outpatient Foley balloon induction</arm_group_label>
    <other_name>18-French Bard catheter</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&amp;D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.&#xD;
Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.</description>
    <arm_group_label>inpatient Foley balloon induction</arm_group_label>
    <arm_group_label>outpatient Foley balloon induction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Viable Intrauterine Pregnancy&#xD;
&#xD;
          -  Greater than or equal to 37 weeks gestation on date of induction&#xD;
&#xD;
          -  Cephalic Presentation&#xD;
&#xD;
          -  Medically indicated induction of labor&#xD;
&#xD;
          -  AFI greater than or equal to 5&#xD;
&#xD;
          -  Patient able to be contacted by phone and demonstrates an understanding of the return&#xD;
             instructions&#xD;
&#xD;
          -  Cervical Dilation 2cm or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Placenta Previa/Low Lying Placenta&#xD;
&#xD;
          -  Placenta accreta/increta/percreta&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding&#xD;
&#xD;
          -  Preeclampsia or HELLP Syndrome&#xD;
&#xD;
          -  Intrauterine Growth Restriction&#xD;
&#xD;
          -  Rupture of Membranes&#xD;
&#xD;
          -  Prior cesarean section or transfundal uterine surgery&#xD;
&#xD;
          -  Twin Gestation&#xD;
&#xD;
          -  Fetal Anomaly&#xD;
&#xD;
          -  Rh Isoimmunization&#xD;
&#xD;
          -  Fetal Demise&#xD;
&#xD;
          -  Uterine Tachysystole&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  HIV Infection&#xD;
&#xD;
          -  Active herpes, hepatitis B or C infection&#xD;
&#xD;
          -  Latex Allergy&#xD;
&#xD;
          -  EFW&gt;4000g&#xD;
&#xD;
          -  Chorioamnionitis&#xD;
&#xD;
          -  Non-English or Non-Spanish Speaking&#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>Patrick M Mullin, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yen Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Lee, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick M Mullin, MD</last_name>
    <email>pmullin@usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Los Angeles County + University of Southern California Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.</citation>
    <PMID>11704164</PMID>
  </results_reference>
  <results_reference>
    <citation>Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.</citation>
    <PMID>19370687</PMID>
  </results_reference>
  <results_reference>
    <citation>Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.</citation>
    <PMID>23356673</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>March 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Patrick M Mullin, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>labor, induced</keyword>
  <keyword>catheter</keyword>
  <keyword>oxytocin</keyword>
  <keyword>Cesarean section</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</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/NCT02210598
org study id: HS-13-00740
nct id: NCT02210598
lead sponsor: 
has dmc: Yes
This study represents the first randomized trial comparing traditional inpatient induction
      with a transcervical foley catheter versus outpatient induction with immediate removal of a
      transcervical foley catheter. The immediate removal technique allows the induction process to
      begin in the hospital setting, but allows the patient to go home without a foreign body in
      situ. The investigators hypothesize the outpatient group will spend less time hospitalized
      prior to discharge. Additionally, the investigators will explore the vaginal delivery rates
      and maternal/neonatal safety profiles between groups.
This is a randomized controlled trial.

      Patients who are candidates for labor induction and meet inclusion criteria will be
      identified in the obstetrics clinic when they are being scheduled for induction of labor, or
      at a later clinic date. If they agree to participate, patients will be randomized and
      enrolled in the study at that time. Those who consent will be randomized into Group A
      (Experimental Group) and Group B (Control Group). No stratification criteria will be used.

      Patients randomized to the control group will undergo induction of labor using the standard
      foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position,
      an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL
      of sterile saline. One of two methods will be used to place the transcervical foley based on
      provider preference and determination of which method will offer the greatest chance for
      successful placement. Method A is placement of the foley "blindly" by palpation of the
      cervix. Method B utilizes direct visualization with sterile speculum placement. Method will
      be documented in the data collection forms. The catheter will be left in place and IV
      oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if
      not spontaneously extruded.

      Patients randomized to the experimental group will undergo outpatient induction of labor.
      Either of the above two described methods will be used to place an 18 French Foley catheter
      transcervically and its balloon filled with 60mL of sterile saline. The catheter will be
      deflated and removed within 10 minutes of placement. The patient will then undergo a
      non-stress test (NST). If the patient has a reactive NST with no late or variable
      decelerations or uterine tachysystole, the patient will be discharged home with clear return
      precautions and instructions to return to the triage area in 24 hours. When the patient
      returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The
      patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin
      per protocol.

      In accordance with the Friedman curve and current LAC+USC practice, primigravid participants
      will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and
      multigravid participants will be given 14 hours before a failed induction is diagnosed.
      Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any
      obstetric indication as decided by the on-duty house staff. Finally, at patient request,
      intravenous or regional anesthesia will be made available at any time during the labor and
      delivery process.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of inpatient hospitalization (hours)
time frame: time from hospital admission to time to discharge, on average 96 hours
description: compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)
measure: Duration of labor induction (hours)
time frame: time of initiation of labor induction to delivery, on average 24 hours
measure: Cesarean section rate (percentage)
time frame: determined at time of delivery
measure: Duration of oxytocin use during labor induction (hours)
time frame: time of initiation of oxytocin until it is discontinued, on average 18 hours
measure: Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)
time frame: from initiation of labor induction to delivery, on average 24 hours
measure: Rate of patients developing chorioamnionitis during labor induction (percentage)
time frame: from initiation of induction until delivery, on average 24 hours
measure: Rate of patients developing uterine tachysystole during labor induction (percentage)
time frame: from initiation of labor induction to delivery, on average 24 hours
measure: Rate of infants admitted to NICU (percentage)
time frame: on average during the 24 hours following delivery
measure: APGAR score
time frame: at 1 minute, 5 minutes, and 10 minutes after delivery
arm group label: inpatient Foley balloon induction
arm group type: Active Comparator
description: Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
arm group label: outpatient Foley balloon induction
arm group type: Experimental
description: Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.
intervention type: Device
intervention name: inpatient Foley balloon induction
description: The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
arm group label: inpatient Foley balloon induction
other name: 18-French Bard catheter
intervention type: Device
intervention name: outpatient Foley balloon induction
description: The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.
arm group label: outpatient Foley balloon induction
other name: 18-French Bard catheter
intervention type: Drug
intervention name: Oxytocin
description: When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.
Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.
arm group label: inpatient Foley balloon induction
arm group label: outpatient Foley balloon induction
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick M Mullin, MD
role: Study Director
affiliation: University of Southern California
last name: Yen Chan, MD
role: Principal Investigator
affiliation: University of Southern California
last name: Richard Lee, MD
role: Study Director
affiliation: University of Southern California
last name: Patrick M Mullin, MD
email: pmullin@usc.edu
facility: 
status: Recruiting
country: United States
citation: Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PMID: 11704164
citation: Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.
PMID: 19370687
citation: Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
PMID: 23356673
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Patrick M Mullin, MD
investigator title: Associate Professor
mesh term: Oxytocin