<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/NCT03016442</url>
  </required_header>
  <id_info>
    <org_study_id>KanuniSSTRH -3</org_study_id>
    <nct_id>NCT03016442</nct_id>
  </id_info>
  <brief_title>Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the&#xD;
      induction of labor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan&#xD;
      Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local&#xD;
      institutional review board. All the participants will give informed consent before beginning&#xD;
      of the study. Women who agree to participate will be first stratified into nulliparous and&#xD;
      multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a&#xD;
      piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes&#xD;
      will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for&#xD;
      each stratified group. Envelopes will be then shuffled and placed in boxes marked&#xD;
      'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure.&#xD;
      The allocated envelope will be opened by the clinician performing the initial vaginal&#xD;
      examination just prior to that examination.&#xD;
&#xD;
      In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical&#xD;
      Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct&#xD;
      visualisation during a sterile speculum examination. Once both balloon enter the cervical&#xD;
      canal, the first balloon is filled with 40 ml saline above the level of the internal os. The&#xD;
      second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled&#xD;
      with 60 ml of saline. The external end of the device is taped without traction to the medial&#xD;
      aspect of the woman's thigh. After completion of the device placement, patients undergo&#xD;
      continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double&#xD;
      ballon is placed for 12 hours .&#xD;
&#xD;
      In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the&#xD;
      patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are&#xD;
      allowed to ambulate.&#xD;
&#xD;
      After 12 hours oxytocin isadministered using a standard dose regimen to all patients.&#xD;
&#xD;
      Primary and secondary outcomes are measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal delivery after initiation of ripening within 24 hours</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence of cesarean section</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Labor Induction</condition>
  <arm_group>
    <arm_group_label>Cook double balloon catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dinoprostone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cook Double Balloon Catheter</intervention_name>
    <description>A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours</description>
    <arm_group_label>Cook double balloon catheter</arm_group_label>
    <other_name>The Obstetric Cook Double Balloon Catheter</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dinoprostone</intervention_name>
    <description>10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.</description>
    <arm_group_label>Dinoprostone</arm_group_label>
    <other_name>Dinoprostone vaginal insert</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible women have obstetric or medical indications for labor induction with intact&#xD;
             membranes&#xD;
&#xD;
          -  singleton pregnancies,&#xD;
&#xD;
          -  vertex presentations&#xD;
&#xD;
          -  low Bishop scores ≤6&#xD;
&#xD;
          -  gestational age ≥34 w&#xD;
&#xD;
          -  reassuring fetal heart tracing on admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are placenta previa&#xD;
&#xD;
          -  unexplained vaginal bleeding&#xD;
&#xD;
          -  nonvertex presentation&#xD;
&#xD;
          -  intrauterine fetal death&#xD;
&#xD;
          -  prior cesarean delivery&#xD;
&#xD;
          -  any scarred uterus&#xD;
&#xD;
          -  any other contraindications for vaginal delivery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gonca Yetkin Yıldırım, MD</last_name>
    <phone>+90 5323532205</phone>
    <email>goncayetkinyildirim@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nadiye Köroğlu, MD</last_name>
    <phone>+90 5058065348</phone>
    <email>nadiye_dugan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34325</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gonca Yetkin Yıldırım, MD</last_name>
      <phone>+90 532 3532205</phone>
      <email>goncayetkinyildirim@gmal.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22704766</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.</citation>
    <PMID>22704766</PMID>
  </reference>
  <reference>
    <citation>Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.</citation>
    <PMID>27018464</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gonca Yetkin Yildirim</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Double balloon catheter</keyword>
  <keyword>Dinoprostone</keyword>
  <keyword>Labor induction</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>
  <!-- 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/NCT03016442
org study id: KanuniSSTRH -3
nct id: NCT03016442
lead sponsor: 
has dmc: No
Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the
      induction of labor
The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan
      Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local
      institutional review board. All the participants will give informed consent before beginning
      of the study. Women who agree to participate will be first stratified into nulliparous and
      multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a
      piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes
      will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for
      each stratified group. Envelopes will be then shuffled and placed in boxes marked
      'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure.
      The allocated envelope will be opened by the clinician performing the initial vaginal
      examination just prior to that examination.

      In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical
      Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct
      visualisation during a sterile speculum examination. Once both balloon enter the cervical
      canal, the first balloon is filled with 40 ml saline above the level of the internal os. The
      second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled
      with 60 ml of saline. The external end of the device is taped without traction to the medial
      aspect of the woman's thigh. After completion of the device placement, patients undergo
      continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double
      ballon is placed for 12 hours .

      In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the
      patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are
      allowed to ambulate.

      After 12 hours oxytocin isadministered using a standard dose regimen to all patients.

      Primary and secondary outcomes are measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Vaginal delivery after initiation of ripening within 24 hours
time frame: 24 hours
measure: Occurence of cesarean section
time frame: 24 hours
arm group label: Cook double balloon catheter
arm group type: Experimental
description: A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours
arm group label: Dinoprostone
arm group type: Active Comparator
description: 10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
intervention type: Device
intervention name: Cook Double Balloon Catheter
description: A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours
arm group label: Cook double balloon catheter
other name: The Obstetric Cook Double Balloon Catheter
intervention type: Drug
intervention name: Dinoprostone
description: 10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
arm group label: Dinoprostone
other name: Dinoprostone vaginal insert
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gonca Yetkin Yıldırım, MD
phone: +90 5323532205
email: goncayetkinyildirim@gmail.com
last name: Nadiye Köroğlu, MD
phone: +90 5058065348
email: nadiye_dugan@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
url: http://www.ncbi.nlm.nih.gov/pubmed/22704766
description: Related Info
citation: Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.
PMID: 22704766
citation: Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
PMID: 27018464
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Gonca Yetkin Yildirim
investigator title: MD
mesh term: Dinoprostone
sharing ipd: No