<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/NCT01720394</url>
  </required_header>
  <id_info>
    <org_study_id>MUG-CRB-2012</org_study_id>
    <nct_id>NCT01720394</nct_id>
  </id_info>
  <brief_title>Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert</brief_title>
  <official_title>Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum Klagenfurt am Wörthersee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Salzburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Hartberg, Austria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Braunau, Austria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter&#xD;
      for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not&#xD;
      greater than 6) compared to medical treatment using a dinoprostone&#xD;
      slow-release-vaginal-insert.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>Phase 4</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>time interval from primary treatment to delivery</measure>
    <time_frame>maximum of 72 hours</time_frame>
    <description>the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progress of labor</measure>
    <time_frame>maximum of 72 hours</time_frame>
    <description>time from balloon-application to dilatation of the cervix (cervical opening &gt; 3cm, or Bishop Score ≥ 9 ) in therapy arm 1 and from dinoprostone-vaginal-insert-application to dilatation of the cervix (cervical opening &gt; 3cm, or Bishop Score ≥ 9 ) in therapy arm 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vaginal delivery</measure>
    <time_frame>maximum of 72 hours</time_frame>
    <description>Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>failed induction of labor</measure>
    <time_frame>maximum of 72 hours</time_frame>
    <description>Number of patients who received caesarean section after frustrating induction of labor. Frustrating induction is defined as application of the cervical-ripening-balloon + 2 times application of dinoprostone-vaginal-insert in therapy arm 1 and 3 times application of dinoprostone-vaginal-insert in therapy arm 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's satisfaction</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 5-7 days</time_frame>
    <description>Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal parameters</measure>
    <time_frame>primary treatment - 48h postpartal, leading to a maximum time frame of 5 days</time_frame>
    <description>signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal parameters</measure>
    <time_frame>primary treatment - fetal hospital discharge, with an expected maximum of 3 months</time_frame>
    <description>umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">253</enrollment>
  <condition>Cervical Ripening</condition>
  <condition>Induction of Labor</condition>
  <arm_group>
    <arm_group_label>Cervical ripening balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propess</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cervical Ripening Balloon, Cook Medical Inc.</intervention_name>
    <description>Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.</description>
    <arm_group_label>Cervical ripening balloon</arm_group_label>
    <other_name>Cook cervical ripening balloon, Cook OB/GYN, Spencer, IN, 47460 USA - CE 0088, 400470E</other_name>
    <other_name>Propess-vaginal-insert (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dinoprostone</intervention_name>
    <description>Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2.</description>
    <arm_group_label>Propess</arm_group_label>
    <other_name>Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical indication for induction of labor&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  no PROM&#xD;
&#xD;
          -  37+0 - 42+0 weeks of gestation&#xD;
&#xD;
          -  Bishop-Score ≤ 6&#xD;
&#xD;
          -  no contra-indication for medical induction of labor&#xD;
&#xD;
          -  no clinical signs of infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fetal anomalies&#xD;
&#xD;
          -  contra-indications for medical induction of labor&#xD;
&#xD;
          -  placental pathologies&#xD;
&#xD;
          -  St.p. surgery with opening the uterine cavity (incl. caesarean section)&#xD;
&#xD;
          -  PROM&#xD;
&#xD;
          -  multiple gestations&#xD;
&#xD;
          -  &lt; 37-0 weeks of gestation&#xD;
&#xD;
          -  St.p. cervical tear&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philipp Klaritsch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philipp Reif, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philipp Reif, MD</last_name>
    <phone>004331638580053</phone>
    <email>philipp.reif@medunigraz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philipp Klaritsch, MD</last_name>
    <phone>004331638581641</phone>
    <email>philipp.klaritsch@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau</name>
      <address>
        <city>Braunau</city>
        <zip>A-5280</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christiane Freudl, MD</last_name>
      <phone>0043-7722-804-5858</phone>
      <email>Christiane.Freudl@khbr.at</email>
    </contact>
    <contact_backup>
      <last_name>Gottfried Hasenöhrl, MD</last_name>
      <phone>0043- 7722-804-5800</phone>
      <email>gottfried.haseoehrl@khbr.at</email>
    </contact_backup>
    <investigator>
      <last_name>Christiane Freudl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gottfried Hasenöhrl</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philipp Reif, MD</last_name>
      <phone>004331638580053</phone>
      <email>philipp.reif@medunigraz.at</email>
    </contact>
    <contact_backup>
      <last_name>Philipp Klaritsch, MD</last_name>
      <phone>004331638581641</phone>
      <email>philipp.klaritsch@medunigraz.at</email>
    </contact_backup>
    <investigator>
      <last_name>Philipp Reif, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philipp Klaritsch, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg</name>
      <address>
        <city>Hartberg</city>
        <zip>A-8230</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Schosteritsch, MD</last_name>
      <email>Stefan.Schosteritsch@lkh-hartberg.at</email>
    </contact>
    <investigator>
      <last_name>Saskia de Bruin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johanna Tiechl, MD</last_name>
      <email>Johanna.Tiechl@i-med.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Angela Ramoni, MD</last_name>
      <phone>004351250481444</phone>
      <email>Angela.RAMONI@uki.at</email>
    </contact_backup>
    <investigator>
      <last_name>Johanna Tiechl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>A-9020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christoph Herbst, MD</last_name>
      <phone>0043 463 438 26417</phone>
      <email>christoph.herbst@kabeg.at</email>
    </contact>
    <contact_backup>
      <last_name>Daniela Wolin, MD</last_name>
      <phone>0043 463 438 0</phone>
      <email>daniela.wolin@kabeg.at</email>
    </contact_backup>
    <investigator>
      <last_name>Manfred Mörtl, MD, MBA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Herbst, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität</name>
      <address>
        <city>Salzburg</city>
        <zip>A-5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudius Fazelnia, MD</last_name>
      <email>c.fazelnia@salk.at</email>
    </contact>
    <investigator>
      <last_name>Claudius Fazelnia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hanns Helmer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&amp;objectHandle=DBMaint&amp;APPLICATION_NAME=drugportal&amp;actionHandle=default&amp;nextPage=jsp/drugportal/ResultScreen.jsp&amp;TXTSUPERLISTID=0000363246&amp;QV1=DINOPROSTONE</url>
    <description>Drug Information on Dinoprostone</description>
  </link>
  <reference>
    <citation>Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S. Births: final data for 2004. Natl Vital Stat Rep. 2006 Sep 29;55(1):1-101.</citation>
    <PMID>17051727</PMID>
  </reference>
  <reference>
    <citation>Sherman DJ, Frenkel E, Tovbin J, Arieli S, Caspi E, Bukovsky I. Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review. Obstet Gynecol Surv. 1996 Oct;51(10):621-7. doi: 10.1097/00006254-199610000-00022.</citation>
    <PMID>8888040</PMID>
  </reference>
  <reference>
    <citation>Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.</citation>
    <PMID>1876873</PMID>
  </reference>
  <reference>
    <citation>Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.</citation>
    <PMID>11687101</PMID>
  </reference>
  <reference>
    <citation>Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.</citation>
    <PMID>18715244</PMID>
  </reference>
  <reference>
    <citation>Kehl S, Ehard A, Berlit S, Spaich S, Sutterlin M, Siemer J. Combination of misoprostol and mechanical dilation for induction of labour: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):315-9. doi: 10.1016/j.ejogrb.2011.09.010. Epub 2011 Oct 2.</citation>
    <PMID>21962943</PMID>
  </reference>
  <reference>
    <citation>Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28. Erratum In: BJOG. 2011 Mar;118(4):521. McCleery, S [corrected to McChlery, S].</citation>
    <PMID>19656148</PMID>
  </reference>
  <reference>
    <citation>Mei-Dan E, Walfisch A, Suarez-Easton S, Hallak M. Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med. 2012 Jun;25(6):723-7. doi: 10.3109/14767058.2011.591459. Epub 2011 Aug 2.</citation>
    <PMID>21806490</PMID>
  </reference>
  <reference>
    <citation>Calder AA. Review of prostaglandin use in labour induction. Br J Obstet Gynaecol. 1997 Oct;104 Suppl 15:2-7; discussion 20-5. No abstract available.</citation>
    <PMID>9366720</PMID>
  </reference>
  <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>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dinoprostone</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/NCT01720394
org study id: MUG-CRB-2012
nct id: NCT01720394
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter
      for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not
      greater than 6) compared to medical treatment using a dinoprostone
      slow-release-vaginal-insert.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time interval from primary treatment to delivery
time frame: maximum of 72 hours
description: the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured
measure: progress of labor
time frame: maximum of 72 hours
description: time from balloon-application to dilatation of the cervix (cervical opening > 3cm, or Bishop Score ≥ 9 ) in therapy arm 1 and from dinoprostone-vaginal-insert-application to dilatation of the cervix (cervical opening > 3cm, or Bishop Score ≥ 9 ) in therapy arm 2
measure: vaginal delivery
time frame: maximum of 72 hours
description: Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.
measure: failed induction of labor
time frame: maximum of 72 hours
description: Number of patients who received caesarean section after frustrating induction of labor. Frustrating induction is defined as application of the cervical-ripening-balloon + 2 times application of dinoprostone-vaginal-insert in therapy arm 1 and 3 times application of dinoprostone-vaginal-insert in therapy arm 2.
measure: patient's satisfaction
time frame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days
description: Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery
measure: maternal parameters
time frame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days
description: signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.
measure: fetal parameters
time frame: primary treatment - fetal hospital discharge, with an expected maximum of 3 months
description: umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.
arm group label: Cervical ripening balloon
arm group type: Experimental
description: primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.
arm group label: Propess
arm group type: Active Comparator
description: Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)
intervention type: Device
intervention name: Cervical Ripening Balloon, Cook Medical Inc.
description: Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
arm group label: Cervical ripening balloon
other name: Cook cervical ripening balloon, Cook OB/GYN, Spencer, IN, 47460 USA - CE 0088, 400470E
other name: Propess-vaginal-insert (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria
intervention type: Drug
intervention name: Dinoprostone
description: Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2.
arm group label: Propess
other name: Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Klaritsch, MD
role: Study Chair
affiliation: Medical University of Graz
last name: Philipp Reif, MD
role: Principal Investigator
affiliation: Medical University of Graz
last name: Philipp Reif, MD
phone: 004331638580053
email: philipp.reif@medunigraz.at
last name: Philipp Klaritsch, MD
phone: 004331638581641
email: philipp.klaritsch@medunigraz.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
country: Austria
url: http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000363246&QV1=DINOPROSTONE
description: Drug Information on Dinoprostone
citation: Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S. Births: final data for 2004. Natl Vital Stat Rep. 2006 Sep 29;55(1):1-101.
PMID: 17051727
citation: Sherman DJ, Frenkel E, Tovbin J, Arieli S, Caspi E, Bukovsky I. Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review. Obstet Gynecol Surv. 1996 Oct;51(10):621-7. doi: 10.1097/00006254-199610000-00022.
PMID: 8888040
citation: Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.
PMID: 1876873
citation: Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.
PMID: 11687101
citation: Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.
PMID: 18715244
citation: Kehl S, Ehard A, Berlit S, Spaich S, Sutterlin M, Siemer J. Combination of misoprostol and mechanical dilation for induction of labour: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):315-9. doi: 10.1016/j.ejogrb.2011.09.010. Epub 2011 Oct 2.
PMID: 21962943
citation: Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28. Erratum In: BJOG. 2011 Mar;118(4):521. McCleery, S [corrected to McChlery, S].
PMID: 19656148
citation: Mei-Dan E, Walfisch A, Suarez-Easton S, Hallak M. Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med. 2012 Jun;25(6):723-7. doi: 10.3109/14767058.2011.591459. Epub 2011 Aug 2.
PMID: 21806490
citation: Calder AA. Review of prostaglandin use in labour induction. Br J Obstet Gynaecol. 1997 Oct;104 Suppl 15:2-7; discussion 20-5. No abstract available.
PMID: 9366720
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
responsible party type: Sponsor
mesh term: Dinoprostone