<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/NCT04454346</url>
  </required_header>
  <id_info>
    <org_study_id>2020/06</org_study_id>
    <nct_id>NCT04454346</nct_id>
  </id_info>
  <brief_title>Double Foley Catheter For Cervical Ripening</brief_title>
  <official_title>Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the efficacy of three mechanical devices for pre-induction of labour cervical&#xD;
      ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook&#xD;
      cervical ripening balloon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter&#xD;
      group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly&#xD;
      allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon&#xD;
      catheter. Removal of the catheters is planned approximately 12 h after insertion if&#xD;
      spontaneous expulsion occurred. The main outcome measures include changes in Bishop score,&#xD;
      insertion to delivery time, mode of delivery and occurrence of adverse effects.&#xD;
&#xD;
      Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters&#xD;
      are connected with sterile suture from the hole end and where the balloons borders end. Both&#xD;
      catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter&#xD;
      full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by&#xD;
      applying traction and full with 80 mL of normal saline. The cervix between two balloons of&#xD;
      Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's&#xD;
      similar to Cook balloon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">November 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>vaginal delivery within 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>the time from applying catheter to delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ripening success</measure>
    <time_frame>12 hours</time_frame>
    <description>Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain score</measure>
    <time_frame>36 hours</time_frame>
    <description>The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Induction of Labour</condition>
  <arm_group>
    <arm_group_label>Double Foley Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients allocated to this arm were randomly and did not differ from the Single Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. The connected FCs were inserted into the cervix using long forceps and advanced to the internal os level. One of the Foley balloons was inflated with 80 ml of saline, and the other FC, now the cervicovaginal balloon, was pulled out with mild traction until the balloon could be visualized and inflated with 20 ml of saline. The vaginal speculum was removed, and the cervicovaginal balloon was inflated further to a total of 80 ml of saline. Both catheters were taped to the inner aspect of the thigh without tension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Foley Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. a 16-F FC was inserted into the cervix using long forceps. Then, the balloon was inflated with 80 ml of saline using a standard 20 ml syringe. The catheter was then pulled out until the balloon covered the internal os. The speculum was removed, and the catheter was fixed under slight tension to the inner aspect of the thigh</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cook Balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Single Foley Catheter arm regard to patients' demographic features and characteristics. Cook cervical ripening group, the device was applied according to the manufacturer's instructions, and each balloon was inflated with 80 ml saline. The catheter was taped to the inner aspect of the thigh without tension.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double Foley Catheter For Ripening The Unfavorable Cervix</intervention_name>
    <description>New method</description>
    <arm_group_label>Cook Balloon</arm_group_label>
    <arm_group_label>Double Foley Catheter</arm_group_label>
    <arm_group_label>Single Foley Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with term pregnancy,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous&#xD;
             uterine scars, estimated fetal weight above 4500&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet Obut, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 8, 2022</last_update_submitted>
  <last_update_submitted_qc>January 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Obut</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Double Foley Catheter, Cook balloon, Foley catheter</keyword>
  <!-- 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/NCT04454346
org study id: 2020/06
nct id: NCT04454346
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the efficacy of three mechanical devices for pre-induction of labour cervical
      ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook
      cervical ripening balloon.
This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter
      group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly
      allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon
      catheter. Removal of the catheters is planned approximately 12 h after insertion if
      spontaneous expulsion occurred. The main outcome measures include changes in Bishop score,
      insertion to delivery time, mode of delivery and occurrence of adverse effects.

      Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters
      are connected with sterile suture from the hole end and where the balloons borders end. Both
      catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter
      full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by
      applying traction and full with 80 mL of normal saline. The cervix between two balloons of
      Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's
      similar to Cook balloon.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: vaginal delivery within 24 hours
time frame: 24 hours
description: the time from applying catheter to delivery
measure: ripening success
time frame: 12 hours
description: Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score
measure: pain score
time frame: 36 hours
description: The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain).
arm group label: Double Foley Catheter
arm group type: Experimental
description: The patients allocated to this arm were randomly and did not differ from the Single Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. The connected FCs were inserted into the cervix using long forceps and advanced to the internal os level. One of the Foley balloons was inflated with 80 ml of saline, and the other FC, now the cervicovaginal balloon, was pulled out with mild traction until the balloon could be visualized and inflated with 20 ml of saline. The vaginal speculum was removed, and the cervicovaginal balloon was inflated further to a total of 80 ml of saline. Both catheters were taped to the inner aspect of the thigh without tension
arm group label: Single Foley Catheter
arm group type: Experimental
description: The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. a 16-F FC was inserted into the cervix using long forceps. Then, the balloon was inflated with 80 ml of saline using a standard 20 ml syringe. The catheter was then pulled out until the balloon covered the internal os. The speculum was removed, and the catheter was fixed under slight tension to the inner aspect of the thigh
arm group label: Cook Balloon
arm group type: Experimental
description: The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Single Foley Catheter arm regard to patients' demographic features and characteristics. Cook cervical ripening group, the device was applied according to the manufacturer's instructions, and each balloon was inflated with 80 ml saline. The catheter was taped to the inner aspect of the thigh without tension.
intervention type: Device
intervention name: Double Foley Catheter For Ripening The Unfavorable Cervix
description: New method
arm group label: Cook Balloon
arm group label: Double Foley Catheter
arm group label: Single Foley Catheter
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mehmet Obut, M.D
role: Study Director
affiliation: Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
investigator full name: Mehmet Obut
investigator title: Medical Doctor