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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
| Medical University Innsbruck | OTHER |
| Klinikum Klagenfurt am Wörthersee | OTHER |
| University of Salzburg |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical ripening balloon | Experimental | 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. |
|
| Propess | Active Comparator | Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Ripening Balloon, Cook Medical Inc. | Device | Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| vaginal delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Reif, MD | Contact | 004331638580053 | philipp.reif@medunigraz.at | |
| Philipp Klaritsch, MD | Contact | 004331638581641 | philipp.klaritsch@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Klaritsch, MD | Medical University of Graz | Study Chair |
| Philipp Reif, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau | Recruiting | Braunau am Inn | A-5280 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17051727 | Background | 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. | |
| 8888040 | Background | 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. |
| Label | URL |
|---|---|
| Drug Information on Dinoprostone | View source |
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| OTHER |
| Hospital Hartberg, Austria | UNKNOWN |
| Hospital Braunau, Austria | UNKNOWN |
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|
| Dinoprostone | Drug | 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. |
|
|
Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2. |
| maximum of 72 hours |
| 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 |
| 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 |
| 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 |
| 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 |
| Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz | Recruiting | Graz | A-8036 | Austria |
|
| Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg | Recruiting | Hartberg | A-8230 | Austria |
|
| Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck | Recruiting | Innsbruck | A-6020 | Austria |
|
| Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee | Not yet recruiting | Klagenfurt | A-9020 | Austria |
|
| Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität | Recruiting | Salzburg | A-5020 | Austria |
|
| Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien | Recruiting | Vienna | A-1090 | Austria |
|
| 1876873 | Background | Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available. |
| 11687101 | Background | 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. |
| 18715244 | Background | 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. |
| 21962943 | Background | 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. |
| 19656148 | Background | 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. |
| 21806490 | Background | 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. |
| 9366720 | Background | 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. |
| 22704766 | Background | 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. |
| 36996264 | Derived | 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. |
| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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