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

September 7, 2018 updated by: Medical University of Graz

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

253

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Braunau, Austria, A-5280
        • Recruiting
        • Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christiane Freudl, MD
        • Sub-Investigator:
          • Gottfried Hasenöhrl
      • Graz, Austria, A-8036
        • Recruiting
        • Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philipp Reif, MD
        • Sub-Investigator:
          • Philipp Klaritsch, MD
      • Hartberg, Austria, A-8230
        • Recruiting
        • Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg
        • Contact:
        • Principal Investigator:
          • Saskia de Bruin, MD
      • Innsbruck, Austria, A-6020
        • Recruiting
        • Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck
        • Contact:
        • Contact:
        • Principal Investigator:
          • Johanna Tiechl, MD
      • Klagenfurt, Austria, A-9020
        • Not yet recruiting
        • Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manfred Mörtl, MD, MBA
        • Sub-Investigator:
          • Christoph Herbst, MD
      • Salzburg, Austria, A-5020
        • Recruiting
        • Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
        • Contact:
        • Principal Investigator:
          • Claudius Fazelnia, MD
      • Vienna, Austria, A-1090
        • Recruiting
        • Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien
        • Principal Investigator:
          • Hanns Helmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time interval from primary treatment to delivery
Time Frame: maximum of 72 hours
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
maximum of 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress of labor
Time Frame: maximum of 72 hours
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
maximum of 72 hours
vaginal delivery
Time Frame: maximum of 72 hours
Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.
maximum of 72 hours
failed induction of labor
Time Frame: maximum of 72 hours
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.
maximum of 72 hours
patient's satisfaction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days
Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery
participants will be followed for the duration of hospital stay, an expected average of 5-7 days
maternal parameters
Time Frame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days
signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.
primary treatment - 48h postpartal, leading to a maximum time frame of 5 days
fetal parameters
Time Frame: primary treatment - fetal hospital discharge, with an expected maximum of 3 months
umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.
primary treatment - fetal hospital discharge, with an expected maximum of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUG-CRB-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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