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

NCT01720394 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2018-09-11

No results posted yet for this 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.

Conditions

  • Cervical Ripening
  • Induction of Labor

Interventions

DEVICE

Cervical Ripening Balloon, Cook Medical Inc.

Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.

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.

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Medical University Innsbruck

    collaborator OTHER

  • Klinikum Klagenfurt am Wörthersee

    collaborator OTHER

  • University of Salzburg

    collaborator OTHER

  • Hospital Hartberg, Austria

    collaborator UNKNOWN

  • Hospital Braunau, Austria

    collaborator UNKNOWN

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Philipp Klaritsch, MD · Medical University of Graz

  • Philipp Reif, MD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720394 on ClinicalTrials.gov