<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/NCT02223949</url>
  </required_header>
  <id_info>
    <org_study_id>0033-14-HYMC</org_study_id>
    <nct_id>NCT02223949</nct_id>
  </id_info>
  <brief_title>Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods</brief_title>
  <official_title>Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether mechanical cervical ripening (using the&#xD;
      Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in&#xD;
      overweight and obese women undergoing labor induction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 2/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>Cesarian section rate</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of excessive uterine activity Incidence of excessive uterine activity</measure>
    <time_frame>24 hours</time_frame>
    <description>At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active labor onset</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of vaginal delivery</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>12-24 hours</time_frame>
    <description>Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ripening-to-delivery time interval</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for oxytocin induction and/or augmentation of labor</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>24 hours</time_frame>
    <description>NVD vs. instrumental</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-partum or postpartum fever</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of meconium staining</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of neonates with 5-minute Apgar scores of less than 7</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of neonates who were admitted to the neonatal intensive care unit</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morbidity and mortality</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">624</enrollment>
  <condition>Obesity</condition>
  <condition>Labor Complications</condition>
  <arm_group>
    <arm_group_label>Cook double balloon catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PGE1 tablet insertion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cook double balloon catheter</intervention_name>
    <arm_group_label>Cook double balloon catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PGE1 tablet</intervention_name>
    <arm_group_label>PGE1 tablet insertion</arm_group_label>
    <other_name>Prostaglandin E1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years of age or older.&#xD;
&#xD;
          -  Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication&#xD;
             for labor induction, including: postdate pregnancy, preeclampsia, gestational or&#xD;
             chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios,&#xD;
             Polyhydramnios, fetal growth restriction, maternal background disease necessitating&#xD;
             delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of&#xD;
             pregnancy.&#xD;
&#xD;
          -  Having a Bishop score of 4 points or less.&#xD;
&#xD;
          -  Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex&#xD;
             presentation, with intact membranes, and absence of significant regular uterine&#xD;
             contraction.&#xD;
&#xD;
          -  Willingness to comply with the protocol for the duration of the study.&#xD;
&#xD;
          -  Has agreed and signed an informed consent after given oral and written explanation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex&#xD;
             presentation, estimated fetal weight of less than 4500 gr).&#xD;
&#xD;
          -  Ruptured membranes.&#xD;
&#xD;
          -  Previous cesarian section or presence of any uterine scar.&#xD;
&#xD;
          -  Documented labor with four or more spontanous uterine contractions per hour.&#xD;
&#xD;
          -  Suspected fetal distress necessitating immediate intervention.&#xD;
&#xD;
          -  Proven malignancy of the cervix.&#xD;
&#xD;
          -  Active vaginal bleeding.&#xD;
&#xD;
          -  Active inflammatory or purulent condition of the lower genital tract.&#xD;
&#xD;
          -  Active asthma.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saja Murra Anabosy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asnat Walfisch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saja Murra Anabosy, MD</last_name>
    <phone>+972 50 9260067</phone>
    <email>saja83@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Asnat Walfisch, MD</last_name>
    <phone>+972 50 4492200</phone>
    <email>asnatwalfisch@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>169</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Saja Murra Anobosy, MD</last_name>
      <phone>+972 50 9260067</phone>
      <email>saja83@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Labor complications</keyword>
  <keyword>Induction of labor</keyword>
  <keyword>Mechanical cervical ripening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alprostadil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223949
org study id: 0033-14-HYMC
nct id: NCT02223949
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate whether mechanical cervical ripening (using the
      Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in
      overweight and obese women undergoing labor induction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cesarian section rate
time frame: 24 hours
measure: Incidence of excessive uterine activity Incidence of excessive uterine activity
time frame: 24 hours
description: At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.
measure: Active labor onset
time frame: 24 hours
measure: Proportion of vaginal delivery
time frame: 24 hours
measure: Treatment failure
time frame: 12-24 hours
description: Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening
measure: The ripening-to-delivery time interval
time frame: 24 hours
measure: Need for oxytocin induction and/or augmentation of labor
time frame: 24 hours
measure: Mode of delivery
time frame: 24 hours
description: NVD vs. instrumental
measure: Intra-partum or postpartum fever
time frame: 48 hours
measure: Incidence of meconium staining
time frame: 24 hours
measure: The proportion of neonates with 5-minute Apgar scores of less than 7
time frame: 48 hours
measure: The number of neonates who were admitted to the neonatal intensive care unit
time frame: 48 hours
measure: morbidity and mortality
time frame: 48 hours
description: Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).
arm group label: Cook double balloon catheter
arm group type: Experimental
description: Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.
arm group label: PGE1 tablet insertion
arm group type: Active Comparator
description: Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.
intervention type: Device
intervention name: Cook double balloon catheter
arm group label: Cook double balloon catheter
intervention type: Drug
intervention name: PGE1 tablet
arm group label: PGE1 tablet insertion
other name: Prostaglandin E1
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Saja Murra Anabosy, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Asnat Walfisch, MD
role: Study Chair
affiliation: Hillel Yaffe Medical Center
last name: Saja Murra Anabosy, MD
phone: +972 50 9260067
email: saja83@gmail.com
last name: Asnat Walfisch, MD
phone: +972 50 4492200
email: asnatwalfisch@yahoo.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Obstetric Labor Complications
mesh term: Alprostadil