Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cervical ripening balloon 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.
Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
Other Names:
|
| Active Comparator: Propess 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- time interval from primary treatment to delivery [maximum of 72 hours]
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
Secondary Outcome Measures
- progress of labor [maximum of 72 hours]
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
- vaginal delivery [maximum of 72 hours]
Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.
- failed induction of labor [maximum of 72 hours]
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.
- patient's satisfaction [participants will be followed for the duration of hospital stay, an expected average of 5-7 days]
Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery
- maternal parameters [primary treatment - 48h postpartal, leading to a maximum time frame of 5 days]
signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.
- fetal parameters [primary treatment - fetal hospital discharge, with an expected maximum of 3 months]
umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau | Braunau | Austria | A-5280 | |
| 2 | Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz | Graz | Austria | A-8036 | |
| 3 | Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg | Hartberg | Austria | A-8230 | |
| 4 | Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck | Innsbruck | Austria | A-6020 | |
| 5 | Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee | Klagenfurt | Austria | A-9020 | |
| 6 | Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität | Salzburg | Austria | A-5020 | |
| 7 | Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien | Vienna | Austria | A-1090 |
Sponsors and Collaborators
- Medical University of Graz
- Medical University of Vienna
- Medical University Innsbruck
- Klinikum Klagenfurt am Wörthersee
- University of Salzburg
- Hospital Hartberg, Austria
- Hospital Braunau, Austria
Investigators
- Study Chair: Philipp Klaritsch, MD, Medical University of Graz
- Principal Investigator: Philipp Reif, MD, Medical University of Graz
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- Calder AA. Review of prostaglandin use in labour induction. Br J Obstet Gynaecol. 1997 Oct;104 Suppl 15:2-7; discussion 20-5. Review.
- 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.
- Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. Review.
- 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.
- 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.
- 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.
- 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].
- 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.
- 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.
- MUG-CRB-2012