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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01720394
Other study ID # MUG-CRB-2012
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 2013
Est. completion date December 2019

Study information

Verified date September 2018
Source Medical University of Graz
Contact Philipp Reif, MD
Phone 004331638580053
Email philipp.reif@medunigraz.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 253
Est. completion date December 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau Braunau
Austria Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz Graz
Austria Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg Hartberg
Austria Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck Innsbruck
Austria Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität Salzburg
Austria Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien Vienna

Sponsors (7)

Lead Sponsor Collaborator
Medical University of Graz Hospital Braunau, Austria, Hospital Hartberg, Austria, Klinikum Klagenfurt am Wörthersee, Medical University Innsbruck, Medical University of Vienna, University of Salzburg

Country where clinical trial is conducted

Austria, 

References & Publications (10)

Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. Review. Update in: Cochrane Database Syst Rev. 2012;3:CD001233. — View Citation

Calder AA. Review of prostaglandin use in labour induction. Br J Obstet Gynaecol. 1997 Oct;104 Suppl 15:2-7; discussion 20-5. Review. — View Citation

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. — View Citation

Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. Review. — View Citation

Kehl S, Ehard A, Berlit S, Spaich S, Sütterlin 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: BJOG. 2011 Mar;118(4):521. McCleery, S [corrected to McChlery, S]. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 maximum of 72 hours
Secondary vaginal delivery Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2. maximum of 72 hours
Secondary 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. maximum of 72 hours
Secondary patient's satisfaction 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
Secondary maternal parameters 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
Secondary 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. primary treatment - fetal hospital discharge, with an expected maximum of 3 months
See also
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