Cervical Ripening Clinical Trial
Official title:
High Volume Foleys Increasing Vaginal Birth (High FIVe Birth) Pilot Trial
Verified date | April 2019 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 130 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sunnybrook Health Sciences Centre | AFP Innovation Fund |
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. Review. — View Citation
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):1239-45. doi: 10.1097/AOG.0b013e3181dec6d0. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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