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Cervical RipeningPhase 4NCT01720394

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

A Phase 4 study testing Cervical Ripening Balloon, Cook Medical Inc. and Dinoprostone in people with Cervical Ripening and Induction of Labor, run by Medical University of Graz at 7 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Ripening, Induction of Labor
What is being tested?
Cervical Ripening Balloon, Cook Medical Inc. and Dinoprostone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
7 sitesAustria
Study dates
Nov 2013to Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • medical indication for induction of labor
  • 18 years of age
  • signed informed consent
  • cephalic presentation
  • no PROM
  • 37+0 - 42+0 weeks of gestation
Show all 9Show fewer
  • Bishop-Score ≤ 6
  • no contra-indication for medical induction of labor
  • no clinical signs of infection

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

Philipp Reif, MD contact

004331638580053

philipp.reif@medunigraz.at

Philipp Klaritsch, MD contact

004331638581641

philipp.klaritsch@medunigraz.at

7 sites in 1 country

Austria7 sites, 7 recruiting

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

    Braunau am Inn, A-5280

    Christiane Freudl, MD, 0043-7722-804-5858, Christiane.Freudl@khbr.at

    Gottfried Hasenöhrl, MD, 0043- 7722-804-5800, gottfried.haseoehrl@khbr.at

    Recruiting

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz

    Graz, A-8036

    Philipp Reif, MD, 004331638580053, philipp.reif@medunigraz.at

    Philipp Klaritsch, MD, 004331638581641, philipp.klaritsch@medunigraz.at

    Recruiting

  • Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg

    Hartberg, A-8230

    Stefan Schosteritsch, MD, Stefan.Schosteritsch@lkh-hartberg.at

    Saskia de Bruin, MD

    Recruiting

  • Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck

    Innsbruck, A-6020

    Johanna Tiechl, MD, Johanna.Tiechl@i-med.ac.at

    Angela Ramoni, MD, 004351250481444, Angela.RAMONI@uki.at

    Recruiting

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

    Klagenfurt, A-9020

    Christoph Herbst, MD, 0043 463 438 26417, christoph.herbst@kabeg.at

    Daniela Wolin, MD, 0043 463 438 0, daniela.wolin@kabeg.at

    Not yet recruiting

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

    Salzburg, A-5020

    Claudius Fazelnia, MD, c.fazelnia@salk.at

    Claudius Fazelnia, MD

    Recruiting

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

    Vienna, A-1090

    Hanns Helmer, MD

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Being tested
Cervical Ripening Balloon, Cook Medical Inc., Dinoprostone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Ripening Balloon, Cook Medical Inc.Device

    Also called 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

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

  • DinoprostoneDrug

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

    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.

Study groups in NCT01720394
Study groupRoleWhat they receive
Cervical ripening balloonExperimentalprimary 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.
Receives: Device: Cervical Ripening Balloon, Cook Medical Inc.
PropessActive comparatorPrimary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)
Receives: Drug: Dinoprostone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: maximum of 72 hours

Secondary outcomes (6)

  1. progress of labor

    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

    Measured: maximum of 72 hours

  2. vaginal delivery

    Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.

    Measured: maximum of 72 hours

  3. failed induction of labor

    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.

    Measured: maximum of 72 hours

  4. patient's satisfaction

    Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery

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

  5. maternal parameters

    signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.

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

  6. fetal parameters

    umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.

    Measured: primary treatment - fetal hospital discharge, with an expected maximum of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
253 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720394
Sponsor's protocol ID
MUG-CRB-2012
Status last verified
Sep 2018
First submitted
25 Jun 2012
Last updated
11 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17051727

  • 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.

    PubMed 8888040

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

    PubMed 1876873

  • 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.

    PubMed 11687101

  • 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.

    PubMed 18715244

  • 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.

    PubMed 21962943

  • 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.

    PubMed 19656148

  • 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.

    PubMed 21806490

  • 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.

    PubMed 9366720

  • 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.

    PubMed 22704766

  • 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.

    PubMed 36996264

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cervical Ripening Balloon, Cook Medical Inc. and Dinoprostone in people with Cervical Ripening and Induction of Labor, run by Medical University of Graz at 7 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Philipp Reif, MD (004331638580053, philipp.reif@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time interval from primary treatment to delivery (time frame: maximum of 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720394, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.

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