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Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of Graz
Sponsor:
Collaborators:
Medical University of Vienna
Medical University Innsbruck
Klinikum Klagenfurt am Wörthersee
University of Salzburg
Hospital Hartberg, Austria
Hospital Braunau, Austria
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01720394
First received: June 25, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cervical Ripening
Induction of Labor
Device: Cervical Ripening Balloon, Cook Medical Inc.
Drug: Dinoprostone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • time interval from primary treatment to delivery [ Time Frame: maximum of 72 hours ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • progress of labor [ Time Frame: maximum of 72 hours ] [ Designated as safety issue: Yes ]
    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

  • vaginal delivery [ Time Frame: maximum of 72 hours ] [ Designated as safety issue: Yes ]
    Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.

  • failed induction of labor [ Time Frame: maximum of 72 hours ] [ Designated as safety issue: Yes ]
    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.

  • patient's satisfaction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days ] [ Designated as safety issue: No ]
    Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery

  • maternal parameters [ Time Frame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days ] [ Designated as safety issue: Yes ]
    signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.

  • fetal parameters [ Time Frame: primary treatment - fetal hospital discharge, with an expected maximum of 3 months ] [ Designated as safety issue: Yes ]
    umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.


Estimated Enrollment: 253
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical ripening balloon
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.
Device: Cervical Ripening Balloon, Cook Medical Inc.
Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
Other Names:
  • Cook cervical ripening balloon, Cook OB/GYN, Spencer, IN, 47460 USA - CE 0088, 400470E
  • Propess-vaginal-insert (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria
Active Comparator: Propess
Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)
Drug: Dinoprostone
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.
Other Name: Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical indication for induction of labor
  • 18 years of age
  • signed informed consent
  • cephalic presentation
  • no PROM
  • 37+0 - 42+0 weeks of gestation
  • Bishop-Score ≤ 6
  • no contra-indication for medical induction of labor
  • no clinical signs of infection

Exclusion Criteria:

  • fetal anomalies
  • contra-indications for medical induction of labor
  • placental pathologies
  • St.p. surgery with opening the uterine cavity (incl. caesarean section)
  • PROM
  • multiple gestations
  • < 37-0 weeks of gestation
  • St.p. cervical tear
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720394

Contacts
Contact: Philipp Reif, MD 004331638580053 philipp.reif@medunigraz.at
Contact: Philipp Klaritsch, MD 004331638581641 philipp.klaritsch@medunigraz.at

Locations
Austria
Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau Recruiting
Braunau, Austria, A-5280
Contact: Christiane Freudl, MD    0043-7722-804-5858    Christiane.Freudl@khbr.at   
Contact: Gottfried Hasenöhrl, MD    0043- 7722-804-5800    gottfried.haseoehrl@khbr.at   
Principal Investigator: Christiane Freudl, MD         
Sub-Investigator: Gottfried Hasenöhrl         
Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz Recruiting
Graz, Austria, A-8036
Contact: Philipp Reif, MD    004331638580053    philipp.reif@medunigraz.at   
Contact: Philipp Klaritsch, MD    004331638581641    philipp.klaritsch@medunigraz.at   
Principal Investigator: Philipp Reif, MD         
Sub-Investigator: Philipp Klaritsch, MD         
Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg Recruiting
Hartberg, Austria, A-8230
Contact: Stefan Schosteritsch, MD       Stefan.Schosteritsch@lkh-hartberg.at   
Principal Investigator: Saskia de Bruin, MD         
Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, A-6020
Contact: Johanna Tiechl, MD       Johanna.Tiechl@i-med.ac.at   
Contact: Angela Ramoni, MD    004351250481444    Angela.RAMONI@uki.at   
Principal Investigator: Johanna Tiechl, MD         
Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee Not yet recruiting
Klagenfurt, Austria, A-9020
Contact: Christoph Herbst, MD    0043 463 438 26417    christoph.herbst@kabeg.at   
Contact: Daniela Wolin, MD    0043 463 438 0    daniela.wolin@kabeg.at   
Principal Investigator: Manfred Mörtl, MD, MBA         
Sub-Investigator: Christoph Herbst, MD         
Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität Not yet recruiting
Salzburg, Austria, A-5020
Contact: Claudius Fazelnia, MD       c.fazelnia@salk.at   
Principal Investigator: Claudius Fazelnia, MD         
Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien Not yet recruiting
Vienna, Austria, A-1090
Principal Investigator: Hanns Helmer, MD         
Sponsors and Collaborators
Medical University of Graz
Medical University of Vienna
Medical University Innsbruck
Klinikum Klagenfurt am Wörthersee
University of Salzburg
Hospital Hartberg, Austria
Hospital Braunau, Austria
Investigators
Study Chair: Philipp Klaritsch, MD Medical University of Graz
Principal Investigator: Philipp Reif, MD Medical University of Graz
  More Information

Additional Information:
Publications:

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01720394     History of Changes
Other Study ID Numbers: MUG-CRB-2012
Study First Received: June 25, 2012
Last Updated: August 21, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014