Balloon Catheter Versus Propess for Labour Induction

Summary

This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.

Timeline

Start

2017-09-22

Primary completion

2019-01-31

Completion

2019-05-31

Publications

• Results Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
• Results Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
• Results Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
• Results 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.
• Results Jozwiak M, Oude Rengerink K, Benthem M, van Beek E, Dijksterhuis MG, de Graaf IM, van Huizen ME, Oudijk MA, Papatsonis DN, Perquin DA, Porath M, van der Post JA, Rijnders RJ, Scheepers HC, Spaanderman ME, van Pampus MG, de Leeuw JW, Mol BW, Bloemenkamp KW; PROBAAT Study Group. Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial. Lancet. 2011 Dec 17;378(9809):2095-103. doi: 10.1016/S0140-6736(11)61484-0. Epub 2011 Oct 24.
• Results Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
• Results Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
• Results Howard K, Gerard K, Adelson P, Bryce R, Wilkinson C, Turnbull D. Women's preferences for inpatient and outpatient priming for labour induction: a discrete choice experiment. BMC Health Serv Res. 2014 Jul 30;14:330. doi: 10.1186/1472-6963-14-330.
• Results Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83. doi: 10.1016/s0140-6736(00)02840-3.
• Results Turnbull D, Adelson P, Oster C, Coffey J, Coomblas J, Bryce R, Wilkinson C. The impact of outpatient priming for induction of labour on midwives' work demand, work autonomy and satisfaction. Women Birth. 2013 Sep;26(3):207-12. doi: 10.1016/j.wombi.2013.03.001. Epub 2013 Apr 3.
• Results O'Brien E, Rauf Z, Alfirevic Z, Lavender T. Women's experiences of outpatient induction of labour with remote continuous monitoring. Midwifery. 2013 Apr;29(4):325-31. doi: 10.1016/j.midw.2012.01.014. Epub 2012 Nov 16.
• Results Norman JE, Stock S. Intracervical Foley catheter for induction of labour. Lancet. 2011 Dec 17;378(9809):2054-5. doi: 10.1016/S0140-6736(11)61581-X. Epub 2011 Oct 24. No abstract available.
• Results Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.
• Results Wilkinson C, Adelson P, Turnbull D. A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial. BMC Pregnancy Childbirth. 2015 May 28;15:126. doi: 10.1186/s12884-015-0550-z.
• Scamell M, Meades R, Foya V. Embodiment and the technologies of induction of labour. Midwifery. 2024 Nov;138:104144. doi: 10.1016/j.midw.2024.104144. Epub 2024 Aug 14.
• 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.
• Bhide A, Sedgwick P, Barrett B, Cupples G, Coates R, Goode R, Linton S, McCourt C. Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F). Pilot Feasibility Stud. 2020 Aug 15;6:113. doi: 10.1186/s40814-020-00661-7. eCollection 2020.

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