Clinical trial NCT01720394: Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert
Official title: Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Ripening
Induction of Labor
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: Medical University Innsbruck
name: Klinikum Klagenfurt am Wörthersee
name: University of Salzburg
name: Hospital Hartberg, Austria
name: Hospital Braunau, Austria
First posted: 2012-11-02
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: time interval from primary treatment to delivery
timeFrame: maximum of 72 hours
Secondary outcomes:
measure: progress of labor
timeFrame: maximum of 72 hours
measure: vaginal delivery
timeFrame: maximum of 72 hours
measure: failed induction of labor
timeFrame: maximum of 72 hours
measure: patient's satisfaction
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days
measure: maternal parameters
timeFrame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days
measure: fetal parameters
timeFrame: primary treatment - fetal hospital discharge, with an expected maximum of 3 months
Other outcomes:
Locations:
city: Braunau
country: Austria
facility: Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau
city: Graz
country: Austria
facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz
city: Hartberg
country: Austria
facility: Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg
city: Innsbruck
country: Austria
facility: Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck
city: Klagenfurt
country: Austria
facility: Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee
city: Salzburg
country: Austria
facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
city: Vienna
country: Austria
facility: Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien
Study officials:
affiliation: Medical University of Graz
name: Philipp Klaritsch, MD
role: STUDY_CHAIR
affiliation: Medical University of Graz
name: Philipp Reif, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1097/00006254-199610000-00022.
citation: Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.
citation: 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.
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.
citation: 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.
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.
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.
citation: 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.
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.