<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/NCT03806231</url>
  </required_header>
  <id_info>
    <org_study_id>OutpatientCervidilTrial</org_study_id>
    <nct_id>NCT03806231</nct_id>
  </id_info>
  <brief_title>A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening</brief_title>
  <official_title>A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of labor is a frequently planned obstetric procedure. Induction for women with an&#xD;
      unfavorable cervix (bishop score &lt;6) increases the risk of cesarean section. This risk may be&#xD;
      reduced by ripening or softening the cervix before the induction of labor. This protocol&#xD;
      outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the&#xD;
      post vaginal fornix to soften the cervix in preparation for induction.&#xD;
&#xD;
      This trial is looking at inpatient vs outpatient pre-induction cervical ripening using&#xD;
      Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to&#xD;
      delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.&#xD;
&#xD;
      The investigators hypothesize when compared to patients admitted to the hospital for cervical&#xD;
      ripening:&#xD;
&#xD;
        1. From the time of admission, patients in the outpatient cervical ripening arm will&#xD;
           progress to complete cervical dilation in less time.&#xD;
&#xD;
        2. The total overall cost of care for the encounter will be reduced for the group in the&#xD;
           outpatient cervical ripening arm.&#xD;
&#xD;
        3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor declined to provide further funding/product support.&#xD;
  </why_stopped>
  <start_date type="Actual">August 7, 2019</start_date>
  <completion_date type="Actual">April 11, 2020</completion_date>
  <primary_completion_date type="Actual">December 5, 2019</primary_completion_date>
  <phase>Phase 3</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>Dilation Completion Time</measure>
    <time_frame>Time of admission to completion of dilation (up to 48 hours)</time_frame>
    <description>Time of admission for induction to complete dilation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Cost of Induction Charged to Patient</measure>
    <time_frame>Through study completion (up to 1 year)</time_frame>
    <description>Total hospital charges to patient, as obtained by Intermountain Healthcare billing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction: Survey</measure>
    <time_frame>Time of delivery to discharge (up to 96 hours)</time_frame>
    <description>Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal Delivery Rate</measure>
    <time_frame>Through study completion (up to 1 year)</time_frame>
    <description>Number of patients enrolled who delivered vaginally</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Vaginal Delivery Rate</measure>
    <time_frame>Through study completion (up to 1 year)</time_frame>
    <description>Number of patients enrolled who required an operative vaginal delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cesarean Delivery Rate</measure>
    <time_frame>Through study completion (up to 1 year)</time_frame>
    <description>Number of patients enrolled who had a c-section delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Start of Oxytocin Until Delivery</measure>
    <time_frame>Time oxytocin is administered to time of delivery (up to 24 hours)</time_frame>
    <description>Length of time between patient receiving oxytocin and delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Delivery Until Discharge</measure>
    <time_frame>Time of delivery to discharge (up to 96 hours)</time_frame>
    <description>Length of time between delivery and discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Admission Until Discharge</measure>
    <time_frame>Time of admission to labor and delivery to discharge (up to 96 hours)</time_frame>
    <description>Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infant 5 Minute APGAR Score</measure>
    <time_frame>From delivery to 5 minutes following delivery</time_frame>
    <description>APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of Admission to Postpartum</measure>
    <time_frame>Time of admission to postpartum until discharge (up to 96 hours)</time_frame>
    <description>Length of stay on postpartum unit.</description>
  </other_outcome>
  <other_outcome>
    <measure>NICU Admission</measure>
    <time_frame>Time of admission to NICU to discharge (up to 3 weeks)</time_frame>
    <description>Length of time spent in NICU</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>Outpatient Cervical Ripening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inpatient Cervical Ripening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Outpatient Dinoprostone 10mg</intervention_name>
    <description>Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
    <arm_group_label>Outpatient Cervical Ripening</arm_group_label>
    <other_name>Outpatient Cervidil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inpatient Dinoprostone 10 mg</intervention_name>
    <description>Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
    <arm_group_label>Inpatient Cervical Ripening</arm_group_label>
    <other_name>Inpatient Cervidil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accurate gestational age dating by Intermountain dating criteria placing the patient&#xD;
             between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening&#xD;
&#xD;
          -  Planning to undergo cervical ripening for induction of labor&#xD;
&#xD;
          -  Participants must live &lt;20 minutes away from the enrolling facility, or must stay &lt; 20&#xD;
             minutes away.&#xD;
&#xD;
          -  Pregnant women between the ages of 18 and 41 at the time of enrollment.&#xD;
&#xD;
          -  Fetus in vertex position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational age &lt; 39 weeks or &gt; 41 weeks and 6 days&#xD;
&#xD;
          -  Hypertension (chronic, transitional, gestational, preeclampsia)&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Intrauterine Growth Restriction&#xD;
&#xD;
          -  Anticoagulant therapy or at high risk for thromboembolism&#xD;
&#xD;
          -  Cardiac disease other than class I per American Heart Association (AHA)&#xD;
&#xD;
          -  Prior incision in the contractile portion of the uterus&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG)&#xD;
             criteria: AFI &lt; 5 or deepest vertical pocket &lt;= 2&#xD;
&#xD;
          -  Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) &gt;= 24&#xD;
&#xD;
          -  Cervical dilation &gt;= 3cm&#xD;
&#xD;
          -  Known fetal anomaly that would require advanced neonatal care&#xD;
&#xD;
          -  Pitocin-induction of labor is otherwise contraindicated&#xD;
&#xD;
          -  Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)&#xD;
&#xD;
          -  Fetal distress&#xD;
&#xD;
          -  Unexplained vaginal bleeding during the pregnancy&#xD;
&#xD;
          -  Sensitivity to prostaglandin&#xD;
&#xD;
          -  Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil&#xD;
             package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>41 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Nichols, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dixie Regional Medical Center</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>August 11, 2021</results_first_submitted>
  <results_first_submitted_qc>August 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2021</results_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Ripening</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dinoprostone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03806231/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Outpatient Cervical Ripening</title>
          <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
        </group>
        <group group_id="P2">
          <title>Inpatient Cervical Ripening</title>
          <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Outpatient Cervical Ripening</title>
          <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
        </group>
        <group group_id="B2">
          <title>Inpatient Cervical Ripening</title>
          <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.5" lower_limit="18" upper_limit="27"/>
                    <measurement group_id="B2" value="30.5" lower_limit="24" upper_limit="39"/>
                    <measurement group_id="B3" value="27.5" lower_limit="18" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Dilation Completion Time</title>
        <description>Time of admission for induction to complete dilation.</description>
        <time_frame>Time of admission to completion of dilation (up to 48 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Dilation Completion Time</title>
          <description>Time of admission for induction to complete dilation.</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Cost of Induction Charged to Patient</title>
        <description>Total hospital charges to patient, as obtained by Intermountain Healthcare billing</description>
        <time_frame>Through study completion (up to 1 year)</time_frame>
        <population>Trial terminated prior to meeting sample size for sufficient analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Cost of Induction Charged to Patient</title>
          <description>Total hospital charges to patient, as obtained by Intermountain Healthcare billing</description>
          <population>Trial terminated prior to meeting sample size for sufficient analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction: Survey</title>
        <description>Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.</description>
        <time_frame>Time of delivery to discharge (up to 96 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction: Survey</title>
          <description>Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaginal Delivery Rate</title>
        <description>Number of patients enrolled who delivered vaginally</description>
        <time_frame>Through study completion (up to 1 year)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaginal Delivery Rate</title>
          <description>Number of patients enrolled who delivered vaginally</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Vaginal Delivery Rate</title>
        <description>Number of patients enrolled who required an operative vaginal delivery</description>
        <time_frame>Through study completion (up to 1 year)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Vaginal Delivery Rate</title>
          <description>Number of patients enrolled who required an operative vaginal delivery</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cesarean Delivery Rate</title>
        <description>Number of patients enrolled who had a c-section delivery</description>
        <time_frame>Through study completion (up to 1 year)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Cesarean Delivery Rate</title>
          <description>Number of patients enrolled who had a c-section delivery</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Start of Oxytocin Until Delivery</title>
        <description>Length of time between patient receiving oxytocin and delivery</description>
        <time_frame>Time oxytocin is administered to time of delivery (up to 24 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Start of Oxytocin Until Delivery</title>
          <description>Length of time between patient receiving oxytocin and delivery</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Delivery Until Discharge</title>
        <description>Length of time between delivery and discharge.</description>
        <time_frame>Time of delivery to discharge (up to 96 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Delivery Until Discharge</title>
          <description>Length of time between delivery and discharge.</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Admission Until Discharge</title>
        <description>Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge</description>
        <time_frame>Time of admission to labor and delivery to discharge (up to 96 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Admission Until Discharge</title>
          <description>Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Infant 5 Minute APGAR Score</title>
        <description>APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.</description>
        <time_frame>From delivery to 5 minutes following delivery</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Infant 5 Minute APGAR Score</title>
          <description>APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time of Admission to Postpartum</title>
        <description>Length of stay on postpartum unit.</description>
        <time_frame>Time of admission to postpartum until discharge (up to 96 hours)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Admission to Postpartum</title>
          <description>Length of stay on postpartum unit.</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>NICU Admission</title>
        <description>Length of time spent in NICU</description>
        <time_frame>Time of admission to NICU to discharge (up to 3 weeks)</time_frame>
        <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Outpatient Cervical Ripening</title>
            <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
          </group>
          <group group_id="O2">
            <title>Inpatient Cervical Ripening</title>
            <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
          </group>
        </group_list>
        <measure>
          <title>NICU Admission</title>
          <description>Length of time spent in NICU</description>
          <population>Trial terminated prior to meeting sufficient sample size for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment period - Approximately 5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Outpatient Cervical Ripening</title>
          <description>Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.&#xD;
Outpatient Dinoprostone 10mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.</description>
        </group>
        <group group_id="E2">
          <title>Inpatient Cervical Ripening</title>
          <description>The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.&#xD;
Inpatient Dinoprostone 10 mg: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Non-Serious Adverse Event</sub_title>
                <description>Post-surgical bleeding</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Trial terminated prior to meeting sufficient sample size for outcome analyses.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Molly Adams, Clinical Research Project Coordinator</name_or_title>
      <organization>Intermountain Healthcare</organization>
      <phone>(801)507-7030</phone>
      <email>molly.adams@imail.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03806231
org study id: OutpatientCervidilTrial
nct id: NCT03806231
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Induction of labor is a frequently planned obstetric procedure. Induction for women with an
      unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be
      reduced by ripening or softening the cervix before the induction of labor. This protocol
      outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the
      post vaginal fornix to soften the cervix in preparation for induction.

      This trial is looking at inpatient vs outpatient pre-induction cervical ripening using
      Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to
      delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.

      The investigators hypothesize when compared to patients admitted to the hospital for cervical
      ripening:

        1. From the time of admission, patients in the outpatient cervical ripening arm will
           progress to complete cervical dilation in less time.

        2. The total overall cost of care for the encounter will be reduced for the group in the
           outpatient cervical ripening arm.

        3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dilation Completion Time
time frame: Time of admission to completion of dilation (up to 48 hours)
description: Time of admission for induction to complete dilation.
measure: Total Cost of Induction Charged to Patient
time frame: Through study completion (up to 1 year)
description: Total hospital charges to patient, as obtained by Intermountain Healthcare billing
measure: Patient Satisfaction: Survey
time frame: Time of delivery to discharge (up to 96 hours)
description: Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.
measure: Vaginal Delivery Rate
time frame: Through study completion (up to 1 year)
description: Number of patients enrolled who delivered vaginally
measure: Operative Vaginal Delivery Rate
time frame: Through study completion (up to 1 year)
description: Number of patients enrolled who required an operative vaginal delivery
measure: Cesarean Delivery Rate
time frame: Through study completion (up to 1 year)
description: Number of patients enrolled who had a c-section delivery
measure: Start of Oxytocin Until Delivery
time frame: Time oxytocin is administered to time of delivery (up to 24 hours)
description: Length of time between patient receiving oxytocin and delivery
measure: Time of Delivery Until Discharge
time frame: Time of delivery to discharge (up to 96 hours)
description: Length of time between delivery and discharge.
measure: Time of Admission Until Discharge
time frame: Time of admission to labor and delivery to discharge (up to 96 hours)
description: Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge
measure: Infant 5 Minute APGAR Score
time frame: From delivery to 5 minutes following delivery
description: APGAR score 5 minutes after delivery. The score ranges from 0 to 10 and a score of 7 or above is considered good health.
measure: Time of Admission to Postpartum
time frame: Time of admission to postpartum until discharge (up to 96 hours)
description: Length of stay on postpartum unit.
measure: NICU Admission
time frame: Time of admission to NICU to discharge (up to 3 weeks)
description: Length of time spent in NICU
arm group label: Outpatient Cervical Ripening
arm group type: Experimental
description: Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.
arm group label: Inpatient Cervical Ripening
arm group type: Active Comparator
description: The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.
intervention type: Drug
intervention name: Outpatient Dinoprostone 10mg
description: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.
arm group label: Outpatient Cervical Ripening
other name: Outpatient Cervidil
intervention type: Drug
intervention name: Inpatient Dinoprostone 10 mg
description: Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
arm group label: Inpatient Cervical Ripening
other name: Inpatient Cervidil
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 41 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Nichols, DO
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dinoprostone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Trial terminated prior to meeting sufficient sample size for outcome analyses.
point of contact: 