NCT01720394

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
253

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5.7 years

First QC Date

June 25, 2012

Last Update Submit

September 7, 2018

Conditions

Cervical RipeningInduction of Labor

Outcome Measures

Primary Outcomes (1)

  • time interval from primary treatment to delivery

    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 Outcomes (6)

  • progress of labor

    maximum of 72 hours

  • vaginal delivery

    maximum of 72 hours

  • failed induction of labor

    maximum of 72 hours

  • patient's satisfaction

    participants will be followed for the duration of hospital stay, an expected average of 5-7 days

  • maternal parameters

    primary treatment - 48h postpartal, leading to a maximum time frame of 5 days

  • +1 more secondary outcomes

Study Arms (2)

Cervical ripening balloon

EXPERIMENTAL

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.

Propess

ACTIVE COMPARATOR

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

Interventions

Cervical Ripening Balloon, Cook Medical Inc.DEVICE

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

Also known as: 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
Cervical ripening balloon
DinoprostoneDRUG

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.

Also known as: Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria
Propess

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau

Braunau am Inn, A-5280, Austria

RECRUITING

Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz

Graz, A-8036, Austria

RECRUITING

Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg

Hartberg, A-8230, Austria

RECRUITING

Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck

Innsbruck, A-6020, Austria

RECRUITING

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

Klagenfurt, A-9020, Austria

NOT YET RECRUITING

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

Salzburg, A-5020, Austria

RECRUITING

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

Vienna, A-1090, Austria

RECRUITING

Related Publications (11)

  • 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: 17051727BACKGROUND

  • 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: 8888040BACKGROUND

  • Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.

    PMID: 1876873BACKGROUND

  • 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: 11687101BACKGROUND

  • 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: 18715244BACKGROUND

  • 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: 21962943BACKGROUND

  • 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.

    PMID: 19656148BACKGROUND

  • 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: 21806490BACKGROUND

  • 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: 9366720BACKGROUND

  • 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: 22704766BACKGROUND

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Related Links

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Philipp Klaritsch, MD

    Medical University of Graz

    STUDY CHAIR

  • Philipp Reif, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Reif, MD

CONTACT

004331638580053philipp.reif@medunigraz.at

Philipp Klaritsch, MD

CONTACT

004331638581641philipp.klaritsch@medunigraz.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

November 2, 2012

Study Start

November 1, 2013

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

AU(7)