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

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.

Timeline

Start

2013-11

Primary completion

2019-07

Completion

2019-12

Publications

• 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.
• 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.
• Background Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications