<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/NCT03752073</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000397</org_study_id>
    <nct_id>NCT03752073</nct_id>
  </id_info>
  <brief_title>Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix</brief_title>
  <acronym>CORC</acronym>
  <official_title>Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ochsner Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized prospective trial of two mechanical methods of pre-induction cervical&#xD;
      ripening agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Term, low risk patients requesting elective induction of labor who desire pre-induction&#xD;
      cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening&#xD;
      balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients&#xD;
      present to the hospital for their scheduled induction of labor approximately 12 hours later.&#xD;
&#xD;
      We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent&#xD;
      efficacy in cervical ripening, but that pain scores and patient satisfaction will be better&#xD;
      with the hygroscopic dilators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty enrolling patients&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 1, 2023</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>Time from start of cervical ripening to delivery</measure>
    <time_frame>720-2160 minutes</time_frame>
    <description>Time in minutes from placement of cervical ripening agent to delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain of insertion</measure>
    <time_frame>First hour</time_frame>
    <description>Patient assessment of pain on insertion using pain analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain over duration of cervical ripening</measure>
    <time_frame>12-14 hours</time_frame>
    <description>Patient assessment of pain on admission using pain analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with cervical ripening agent</measure>
    <time_frame>24-36 hours</time_frame>
    <description>Patient survey postpartum day #1 regarding cervical ripening experience</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of device expulsion prior to admission</measure>
    <time_frame>12-14 hours</time_frame>
    <description>Number of patients reporting expulsion of the device prior to planned admission</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of onset of labor prior to planned admission</measure>
    <time_frame>12-14 hours</time_frame>
    <description>Number of patients presenting in active labor prior to planned admission divided by all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of cesarean delivery</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of patients requiring cesarean delivery divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of operative vaginal delivery</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of patients requiring operative vaginal delivery divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of shoulder dystocia</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of intra-amniotic infection</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of patients diagnosed with intra-amniotic infection (maternal temperature &gt;38C, maternal (&gt;120) or fetal (&gt;160) tachycardia) divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of post-partum hemorrhage</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of patients diagnosed with post-partu hemorrhage (QBL &gt;1000 ml) divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>10 minute Apgar score &lt;7</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of infants with 10 minute Apgar score &lt;7 divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Base excess &gt;12</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of infants with base excess &gt;12 divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Umbilical cord gas pH &lt;7</measure>
    <time_frame>12-36 hours</time_frame>
    <description>Number of infants with umbilical cord gas &lt;7 divided by number of all enrolled patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite score of adverse neonatal outcomes</measure>
    <time_frame>12-72 hours</time_frame>
    <description>Composite of perinatal adverse outcomes (the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support)</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite score of serious maternal morbidity or mortality</measure>
    <time_frame>12-72 hours</time_frame>
    <description>Composite score of serious maternal morbidity (e.g. uterine rupture, admission to intensive care unit, septicemia), or death.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Induction of Labor</condition>
  <arm_group>
    <arm_group_label>Trans-cervical cervical balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hygroscopic cervical dilators</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trans-cervical cervical balloon</intervention_name>
    <description>Insertion of Foley Catheter</description>
    <arm_group_label>Trans-cervical cervical balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hygroscopic cervical dilator</intervention_name>
    <description>Insertion of Dilapan-s</description>
    <arm_group_label>Hygroscopic cervical dilators</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 39 and 41 weeks gestational age who desire elective induction of labor,&#xD;
             based on reliable estimated gestational age (defined as ultrasonography performed&#xD;
             before 14 weeks 0 days, or a certain last menstrual period consistent with&#xD;
             ultrasonography performed before 21 weeks 0 days).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Risk factors for placental insufficiency or intra-partum complication such as&#xD;
             intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin&#xD;
             therapy, multiple gestation, history of previous hysterotomy, cholestasis of&#xD;
             pregnancy, placental abnormalities including low lying placenta (&lt; 2 cm from cervical&#xD;
             os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal&#xD;
             demise, etc.&#xD;
&#xD;
          -  2. Simplified Bishop score must be &lt;6 and cervical dilation &lt;2 cm.&#xD;
&#xD;
          -  3. Women must be able to give informed consent.&#xD;
&#xD;
          -  4. Concern regarding fetal well-being, conditions which preclude vaginal birth, group&#xD;
             B strep carriers, patients who are HIV, Hep B or Hep C positive.&#xD;
&#xD;
          -  5. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley&#xD;
             catheter.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigid McCue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ochsner Baptist Hospital</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigid McCue</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <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>
  </reference>
  <reference>
    <citation>Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.</citation>
    <PMID>24347259</PMID>
  </reference>
  <reference>
    <citation>Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.</citation>
    <PMID>8694040</PMID>
  </reference>
  <reference>
    <citation>Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.</citation>
    <PMID>29272277</PMID>
  </reference>
  <results_reference>
    <citation>Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.</citation>
    <PMID>29889751</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 4, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03752073
org study id: STUDY00000397
nct id: NCT03752073
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a randomized prospective trial of two mechanical methods of pre-induction cervical
      ripening agents.
Term, low risk patients requesting elective induction of labor who desire pre-induction
      cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening
      balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients
      present to the hospital for their scheduled induction of labor approximately 12 hours later.

      We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent
      efficacy in cervical ripening, but that pain scores and patient satisfaction will be better
      with the hygroscopic dilators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time from start of cervical ripening to delivery
time frame: 720-2160 minutes
description: Time in minutes from placement of cervical ripening agent to delivery
measure: Pain of insertion
time frame: First hour
description: Patient assessment of pain on insertion using pain analog scale
measure: Pain over duration of cervical ripening
time frame: 12-14 hours
description: Patient assessment of pain on admission using pain analog scale
measure: Patient satisfaction with cervical ripening agent
time frame: 24-36 hours
description: Patient survey postpartum day #1 regarding cervical ripening experience
measure: Rate of device expulsion prior to admission
time frame: 12-14 hours
description: Number of patients reporting expulsion of the device prior to planned admission
measure: Rate of onset of labor prior to planned admission
time frame: 12-14 hours
description: Number of patients presenting in active labor prior to planned admission divided by all enrolled patients
measure: Rate of cesarean delivery
time frame: 12-36 hours
description: Number of patients requiring cesarean delivery divided by number of all enrolled patients
measure: Rate of operative vaginal delivery
time frame: 12-36 hours
description: Number of patients requiring operative vaginal delivery divided by number of all enrolled patients
measure: Incidence of shoulder dystocia
time frame: 12-36 hours
description: Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients
measure: Incidence of intra-amniotic infection
time frame: 12-36 hours
description: Number of patients diagnosed with intra-amniotic infection (maternal temperature >38C, maternal (>120) or fetal (>160) tachycardia) divided by number of all enrolled patients
measure: Incidence of post-partum hemorrhage
time frame: 12-36 hours
description: Number of patients diagnosed with post-partu hemorrhage (QBL >1000 ml) divided by number of all enrolled patients
measure: 10 minute Apgar score <7
time frame: 12-36 hours
description: Number of infants with 10 minute Apgar score <7 divided by number of all enrolled patients
measure: Base excess >12
time frame: 12-36 hours
description: Number of infants with base excess >12 divided by number of all enrolled patients
measure: Umbilical cord gas pH <7
time frame: 12-36 hours
description: Number of infants with umbilical cord gas <7 divided by number of all enrolled patients
measure: Composite score of adverse neonatal outcomes
time frame: 12-72 hours
description: Composite of perinatal adverse outcomes (the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support)
measure: Composite score of serious maternal morbidity or mortality
time frame: 12-72 hours
description: Composite score of serious maternal morbidity (e.g. uterine rupture, admission to intensive care unit, septicemia), or death.
arm group label: Trans-cervical cervical balloon
arm group type: Experimental
description: 17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.
arm group label: Hygroscopic cervical dilators
arm group type: Experimental
description: Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.
intervention type: Device
intervention name: Trans-cervical cervical balloon
description: Insertion of Foley Catheter
arm group label: Trans-cervical cervical balloon
intervention type: Device
intervention name: Hygroscopic cervical dilator
description: Insertion of Dilapan-s
arm group label: Hygroscopic cervical dilators
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brigid McCue, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
facility: 
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: Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
PMID: 24347259
citation: Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8.
PMID: 8694040
citation: Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017.
PMID: 29272277
citation: Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.
PMID: 29889751
responsible party type: Sponsor
sharing ipd: No