<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/NCT04492072</url>
  </required_header>
  <id_info>
    <org_study_id>20D.435</org_study_id>
    <nct_id>NCT04492072</nct_id>
  </id_info>
  <brief_title>Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions</brief_title>
  <acronym>MODE</acronym>
  <official_title>Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to specifically investigate whether oxytocin and mechanical&#xD;
      dilation decreases the rate of cesarean section compared to misoprostol and mechanical&#xD;
      dilation for pregnancies at risk of fetal compromise&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center randomized control trial of two arms. Singleton, cephalic, high risk&#xD;
      pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol&#xD;
      with mechanical dilation.&#xD;
&#xD;
      In group A, receiving misoprostol with mechanical dilation, will serve as the control group.&#xD;
      Group B, oxytocin with mechanical dilation, will serve as the experimental group. The&#xD;
      expected duration of participation begins at induction of labor and concludes at time of&#xD;
      delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">May 26, 2022</completion_date>
  <primary_completion_date type="Actual">May 26, 2022</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>Rate of Cesarean Delivery</measure>
    <time_frame>48 hours</time_frame>
    <description>Total rate of cesarean delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The time interval from induction-to-delivey for vaginal deliveries</measure>
    <time_frame>48 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of vaginal births within 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of misoprostol doses received by each participant</measure>
    <time_frame>24 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of uterine tachysystole</measure>
    <time_frame>24 hours</time_frame>
    <description>Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of each indication for the cesarean delivery</measure>
    <time_frame>48 hours</time_frame>
    <description>Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of operative vaginal delivery</measure>
    <time_frame>48 hours</time_frame>
    <description>Maternal outcome - includes forceps or vacuum assisted deliveries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of intra-amniotic infection</measure>
    <time_frame>48 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of postpartum hemorrhage</measure>
    <time_frame>24 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of Fetal heart rate abnormaliies</measure>
    <time_frame>48 hours</time_frame>
    <description>recurrent late decelerations, bradycardia, or prolonged deceleration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection</measure>
    <time_frame>24 hours</time_frame>
    <description>Maternal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of stillbirth</measure>
    <time_frame>48 hours</time_frame>
    <description>Fetal/Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total rate of Neonatal Apgar scores less than 7 at 5 minutes</measure>
    <time_frame>5 minutes</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total rate of Neonatal RDS</measure>
    <time_frame>96 hours</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total rate of Neonatal admission to the NICU</measure>
    <time_frame>96 hours</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total rate of neonatal arterial umbilical blood pH &lt; 7.1</measure>
    <time_frame>96 hours</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of neonatal Sepsis</measure>
    <time_frame>96 hours</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of Neonatal Death</measure>
    <time_frame>96 hours</time_frame>
    <description>Neonatal outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Misoprostol</condition>
  <condition>Oxytocin</condition>
  <condition>High Risk Pregnancy</condition>
  <arm_group>
    <arm_group_label>Oxytocin with Mechanical Dilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement.&#xD;
If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol with Mechanical Dilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Intervention</description>
    <arm_group_label>Oxytocin with Mechanical Dilation</arm_group_label>
    <other_name>Mechanical Dilation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Control</description>
    <arm_group_label>Misoprostol with Mechanical Dilation</arm_group_label>
    <other_name>Mechanical Dilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age &gt; 18 years old&#xD;
&#xD;
               -  Singleton, or twins with demise of one&#xD;
&#xD;
               -  Cephalic presentation&#xD;
&#xD;
               -  Intact membranes&#xD;
&#xD;
               -  Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia&#xD;
                  with/without severe features, superimposed preeclampsia with/without severe&#xD;
                  features, eclampsia, HELLP)&#xD;
&#xD;
               -  Oligohydramnios (AFI&lt; 5cm and/or MVP &lt;2cm)&#xD;
&#xD;
               -  Fetal growth restriction (EFW or AC &lt;10th percentile) with normal or abnormal&#xD;
                  (elevated, absent, or reversed) Umbilical Artery Dopplers&#xD;
&#xD;
               -  Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal&#xD;
                  movement) prompting induction of labor&#xD;
&#xD;
               -  Suspected placental abruption&#xD;
&#xD;
               -  Poorly controlled pre-gestational diabetes, defined as &gt;50% abnormal glucose&#xD;
                  values requiring increasing doses of anti-glycemic agents &gt;34 weeks, or requiring&#xD;
                  delivery&#xD;
&#xD;
               -  Gestational Age &gt; 22 weeks&#xD;
&#xD;
               -  Bishop score &lt; 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Prior cesarean delivery&#xD;
&#xD;
               -  Allergy to misoprostol&#xD;
&#xD;
               -  Allergy to oxytocin&#xD;
&#xD;
               -  Allergy to silicone/latex&#xD;
&#xD;
               -  Contraindication to vaginal delivery including placenta or vasa previa, Placenta&#xD;
                  accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the&#xD;
                  uterine cavity and necessitating cesarean delivery, active genital herpes,&#xD;
                  transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load &gt;1000&#xD;
                  copies/mL&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
    <investigator_full_name>Leen Al-Hafez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04492072
org study id: 20D.435
nct id: NCT04492072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to specifically investigate whether oxytocin and mechanical
      dilation decreases the rate of cesarean section compared to misoprostol and mechanical
      dilation for pregnancies at risk of fetal compromise
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk
      pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol
      with mechanical dilation.

      In group A, receiving misoprostol with mechanical dilation, will serve as the control group.
      Group B, oxytocin with mechanical dilation, will serve as the experimental group. The
      expected duration of participation begins at induction of labor and concludes at time of
      delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Cesarean Delivery
time frame: 48 hours
description: Total rate of cesarean delivery
measure: The time interval from induction-to-delivey for vaginal deliveries
time frame: 48 hours
description: Maternal outcome
measure: The number of vaginal births within 24 hours
time frame: 24 hours
description: Maternal outcome
measure: The number of misoprostol doses received by each participant
time frame: 24 hours
description: Maternal outcome
measure: The incidence of uterine tachysystole
time frame: 24 hours
description: Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes
measure: The rate of each indication for the cesarean delivery
time frame: 48 hours
description: Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.
measure: The rate of operative vaginal delivery
time frame: 48 hours
description: Maternal outcome - includes forceps or vacuum assisted deliveries
measure: The rate of intra-amniotic infection
time frame: 48 hours
description: Maternal outcome
measure: The rate of postpartum hemorrhage
time frame: 24 hours
description: Maternal outcome
measure: The rate of Fetal heart rate abnormaliies
time frame: 48 hours
description: recurrent late decelerations, bradycardia, or prolonged deceleration
measure: The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection
time frame: 24 hours
description: Maternal outcome
measure: The rate of stillbirth
time frame: 48 hours
description: Fetal/Neonatal outcome
measure: The total rate of Neonatal Apgar scores less than 7 at 5 minutes
time frame: 5 minutes
description: Neonatal outcome
measure: The total rate of Neonatal RDS
time frame: 96 hours
description: Neonatal outcome
measure: The total rate of Neonatal admission to the NICU
time frame: 96 hours
description: Neonatal outcome
measure: The total rate of neonatal arterial umbilical blood pH < 7.1
time frame: 96 hours
description: Neonatal outcome
measure: The rate of neonatal Sepsis
time frame: 96 hours
description: Neonatal outcome
measure: The rate of Neonatal Death
time frame: 96 hours
description: Neonatal outcome
arm group label: Oxytocin with Mechanical Dilation
arm group type: Experimental
description: If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement.
If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation.
arm group label: Misoprostol with Mechanical Dilation
arm group type: Active Comparator
description: If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur
intervention type: Drug
intervention name: Oxytocin
description: Intervention
arm group label: Oxytocin with Mechanical Dilation
other name: Mechanical Dilation
intervention type: Drug
intervention name: Misoprostol
description: Control
arm group label: Misoprostol with Mechanical Dilation
other name: Mechanical Dilation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Thomas Jefferson University
investigator full name: Leen Al-Hafez
investigator title: Principal Investigator
mesh term: Dilatation, Pathologic
mesh term: Misoprostol
mesh term: Oxytocin
sharing ipd: No