NCT03199820

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

May 31, 2017

Last Update Submit

April 8, 2019

Conditions

Childbirth ProblemsLabor Complication

Outcome Measures

Primary Outcomes (1)

  • feasibility of randomised Induction of Labour Trial in Out-patient setting

    Number of eligible women willing to enrol

    12 months

Study Arms (2)

Cook Cervical balloon

ACTIVE COMPARATOR

Cook cervical double balloon catheter

Device: Cook cervical balloon

Prostin E2 Vaginal suppository

ACTIVE COMPARATOR

Prostaglandin E2 sustained release vaginal insert

Drug: Prostin E2 Vaginal Suppository

Interventions

Cook cervical balloonDEVICE

trans-cervical balloon catheter for out-patient labour induction

Cook Cervical balloon
Prostin E2 Vaginal SuppositoryDRUG

Propess Vaginal suppository for out-patient Labour induction

Also known as: Propess
Prostin E2 Vaginal suppository

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with a single fetus and uncomplicated pregnancy, with a gestational age \> 37+ 0 weeks, needing induction of labour
  • ≥18 years of age
  • No medical risk factors.

You may not qualify if:

  • Out-patient induction of labour is deemed unsuitable for the following women on the grounds of safety -
  • Grand multiparous women (Parity 5 or more)
  • Multiple pregnancy
  • Women with complex medical or obstetric problems (i.e. placenta previa, recurrent antepartum hemorrhage, diabetes, pre-eclampsia, Intrauterine growth restriction (UGR), Obstetric Cholestasis)
  • Previous caesarean section/uterine scar
  • Women who are contracting and/ or requiring analgesia
  • Women who do not fully understand the information leaflet and unable to provide full informed consent
  • Women for whom out-patient induction is unsuitable according to local hospital protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

Location

St Georges University Hospital NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

Location

Related Publications (17)

  • 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.

    PMID: 24222365RESULT

  • 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.

    PMID: 20687092RESULT

  • 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.

    PMID: 23356673RESULT

  • 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.

    PMID: 19656148RESULT

  • 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.

    PMID: 22030144RESULT

  • 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.

    PMID: 22419277RESULT

  • 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.

    PMID: 24824157RESULT

  • 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.

    PMID: 25073486RESULT

  • 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.

    PMID: 11052579RESULT

  • 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.

    PMID: 23561927RESULT

  • 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.

    PMID: 23159160RESULT

  • 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.

    PMID: 22030142RESULT

  • 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.

    PMID: 26850983RESULT

  • 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.

    PMID: 26018581RESULT

  • 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.

    PMID: 39232460DERIVED

  • 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.

    PMID: 36996264DERIVED

  • 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.

    PMID: 32821419DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Amarnath Bhide, MD

    St. George's University Hospitals Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The trial statistician will be blinded to group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A randomised controlled trial of feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 27, 2017

Study Start

September 22, 2017

Primary Completion

January 31, 2019

Study Completion

May 31, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

GB(2)