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

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01720394
• Other study ID #: MUG-CRB-2012
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor

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

External Links

•   Drug Information on Dinoprostone