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

Last updated: September 7, 2018
Sponsor: Medical University of Graz
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01720394
MUG-CRB-2012
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 253
Study Start date:
November 01, 2013
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau

    Braunau, A-5280
    Austria

    Active - Recruiting

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz

    Graz, A-8036
    Austria

    Active - Recruiting

  • Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg

    Hartberg, A-8230
    Austria

    Active - Recruiting

  • Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck

    Innsbruck, A-6020
    Austria

    Active - Recruiting

  • Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee

    Klagenfurt, A-9020
    Austria

    Site Not Available

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

    Salzburg, A-5020
    Austria

    Active - Recruiting

  • Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien

    Vienna, A-1090
    Austria

    Active - Recruiting

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