High Volume Foleys Increasing Vaginal Birth Pilot Trial

NCT02993432 | Unknown

• 1 other identifier: SHS-16-002
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is currently unknown if there is a way to decrease the risk of cesarean delivery when undergoing cervical ripening and induction of labour. Some research suggests a Foley catheter placed through the cervix and filled to 80cc may decrease this risk. We wish to run a large scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section compared to the commonly used medication for cervical ripening, prostaglandins. Before we can undertake a large trial, we need to do a pilot to see if women will agree to participate in this type of study. As well, a pilot will help with trouble shooting prior to a large trail, to improve the chances of successfully answering this clinically important question.

Conditions

Labour; Induced; Pilot Study; Cervical Ripening

Outcome Measures

Primary Outcomes (1)

• The percentage of eligible women who are approached to participate in the study that are enrolled and randomized to either the use of a high volume Foley or prostaglandin for cervical ripening

  The primary outcome measure of percent of women recruited will be captured by the number of women who undergo the randomized intervention divided by the number of women who are approached.

  15 months

Study Arms (2)

Prostaglandin

ACTIVE COMPARATOR

Administration of the prostaglandin for cervical ripening of the clinician's choice, ie Prostin (Prostin E2 Vaginal Gel 1mg intravaginally) or Cervidil (dinoprostone, 10 mg vaginal insert)

Drug: prostaglandin of the clinician's choice

Foley catheter filled to 80cc

EXPERIMENTAL

Insertion of a Foley catheter through the cervix and filling to 80cc

Device: Foley catheter filled to 80cc

Interventions

Foley catheter filled to 80cc DEVICE

A Foley catheter is inserted through the cervix and filled to 80cc

Foley catheter filled to 80cc

prostaglandin of the clinician's choice DRUG

Insertion of the prostaglandin (Prostin (1mg dinoprostone vaginal gel) or Cervidil (10mg vaginal slow release insert)) of the clinicians choice into the vagina for the purpose of cervical ripening

Also known as: Prostin, Cervidil

Prostaglandin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women 37 weeks and 0 days to 41 weeks and 6 days gestational age (term) requiring cervical ripening
• Health care provider feels it is possible to administer either method of cervical ripening.
• Bishop score of 6 or less
• Live, singleton, cephalic fetus
• Availability of personnel to consent and randomize participants

You may not qualify if:

• Non-viable fetus
• Contraindication to cervical ripening, labour induction or labour
• Prior attempt at induction of labour in this pregnancy
• Spontaneous rupture of fetal membranes
• Evidence of labour or regular uterine contractions
• Lack of consent

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• AFP Innovation Fund: collaborator

Related Publications (8)

• Berndl A, El-Chaar D, Murphy K, McDonald S. Does cervical ripening at term using a high volume foley catheter result in a lower caesarean section rate than a low volume foley catheter? A systematic review and meta-analysis. J Obstet Gynaecol Can. 2014 Aug;36(8):678-687. doi: 10.1016/S1701-2163(15)30509-0.

  PMID: 25222162 BACKGROUND

• Leduc D, Biringer A, Lee L, Dy J; CLINICAL PRACTICE OBSTETRICS COMMITTEE; SPECIAL CONTRIBUTORS. Induction of labour. J Obstet Gynaecol Can. 2013 Sep;35(9):840-857. doi: 10.1016/S1701-2163(15)30842-2. English, French.

  PMID: 24099451 BACKGROUND

• 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: 22419277 BACKGROUND

• Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol. 2004 Nov;191(5):1632-6. doi: 10.1016/j.ajog.2004.03.033.

  PMID: 15547534 BACKGROUND

• Kashanian M, Nazemi M, Malakzadegan A. Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening. Int J Gynaecol Obstet. 2009 May;105(2):174-5. doi: 10.1016/j.ijgo.2009.01.005. Epub 2009 Feb 20. No abstract available.

  PMID: 19232606 BACKGROUND

• Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.

  PMID: 20502296 BACKGROUND

• 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: 22030144 BACKGROUND

• 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: 36996264 DERIVED

MeSH Terms

Interventions

KLK15 protein, human; Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Anne ML Berndl, MD MSc

  Sunnybrook Health Sciences Centre,University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor University of Toronto Division of Maternal Fetal Medicine Department of Obstetrics and Gynaecology, Associate Scientist, Sunnybrook Research Institute

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share