Labour; InducedNCT02993432
High Volume Foleys Increasing Vaginal Birth Pilot Trial
A study testing Foley catheter filled to 80cc and prostaglandin of the clinician's choice in people with Labour; Induced and Pilot Study, run by Sunnybrook Health Sciences Centre.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour; Induced, Pilot Study, Cervical Ripening
- What is being tested?
- Foley catheter filled to 80cc and prostaglandin of the clinician's choice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: High Volume Foleys Increasing Vaginal Birth (High FIVe Birth) Pilot Trial
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.
Read the detailed description
Background:
Approximately 1/3 of first-time mothers (nulliparous women) undergoing induction of labour deliver by cesarean. Cesarean delivery can have negative consequences to the initial and subsequent pregnancies. Women who have a cesarean in their first pregnancy are more likely to have a cesarean in their following pregnancies and this group is the largest contributor to the overall cesarean delivery rate. Therefore, targeting interventions that prevent cesareans in nulliparous women undergoing induction of labour will have a substantial impact on the overall cesarean delivery rate.
Adequate ripening or preparing the cervix before induction has been found to decrease the risk of cesarean. This can be done by a variety of methods, such as prostaglandins (a chemical messenger) or a Foley filled to a moderate volume of fluid. These methods have been found to be equal regarding the risk of cesarean delivery. However, a meta-analysis by our team discovered a trend towards a decreased risk of cesarean when cervical ripening is undertaken with Foleys filled to a high volume of fluid (80cc) compared to those filled to a low volume (30cc).Most Canadian Obstetricians use prostaglandins for cervical ripening. To assess if 80cc Foleys result in a lower risk of cesarean, they need to be compared to the Canadian standard of prostaglandins. Therefore a randomized controlled trial is required.
The Greater-Toronto-Area Obstetric (GTA-OB) Network is a group of hospitals committed to facilitating research and will be the setting for the planned large scale trial. The large scale trial will aim to demonstrate a difference in the rate of cesarean from 38% to 31%, which will require the enrollment of 1442 women. It has been estimated that there are 5,437 women who will meet entry criteria in the GTA-OB network each year, if ½ are approached, 20% will need to consent to complete the trial in 3 years. Therefore, this pilot study will determine if this recruitment rate is potentially achievable and will inform design strategies to ensure its success.
The discovery of a simple, non- pharmacological, cost effective manner of cervical ripening that decreases the risk of cesarean would change clinical practice and significantly improve safety for the 33,000 Canadian women and their babies who undergo cervical ripening each year. This pilot trial is a crucial step towards this discovery.
Objectives:
The primary objective for this pilot trial is to determine the probability that an eligible woman will agree to be randomized into the trial comparing 80cc Foleys to prostaglandins for cervical ripening. This study aims to assess if it is possible to obtain a recruitment rate of 20%.
The secondary objective will be a systematic evaluation of the pilot trial process to guide full-scale study design.
- Conditions
- Labour; Induced, Pilot Study, Cervical Ripening
- Being tested
- Foley catheter filled to 80cc, prostaglandin of the clinician's choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheter filled to 80ccDevice
A Foley catheter is inserted through the cervix and filled to 80cc
prostaglandin of the clinician's choiceDrug
Also called Prostin, Cervidil
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Foley catheter filled to 80cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labour; InducedStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Principal investigator, Dr. Anne Berndl, Sunnybrook Health Sciences Centre
- Investigators
- Anne ML Berndl, MD MSc, Principal investigator, Sunnybrook Health Sciences Centre,University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993432
- Sponsor's protocol ID
- SHS-16-002
- Status last verified
- Apr 2019
- First submitted
- 5 Dec 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not currently an IPD sharing plan
Publications
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.
PubMed 25222162Leduc 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.
PubMed 24099451Jozwiak 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.
PubMed 22419277Levy 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.
PubMed 15547534Kashanian 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.
PubMed 19232606Delaney 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.
PubMed 20502296Jozwiak 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.
PubMed 22030144de 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.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Foleys Increasing Vaginal Birth (High FIVe Birth) Pilot Trial
- ClinicalTrials.gov ID
- NCT02993432
- Acronym / sponsor ID
- SHS-16-002
- Conditions
- Labour; Induced, Pilot Study, Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Approximately 1/3 of first-time mothers (nulliparous women) undergoing induction of labour deliver by cesarean. Cesarean delivery can have negative consequences to the initial and subsequent pregnancies. Women who have a cesarean in their first pregnancy are more likely to have a cesarean in their following pregnancies and this group is the largest contributor to the overall cesarean delivery rate. Therefore, targeting interventions that prevent cesareans in nulliparous women undergoing induction of labour will have a substantial impact on the overall cesarean delivery rate.
Adequate ripening or preparing the cervix before induction has been found to decrease the risk of cesarean. This can be done by a variety of methods, such as prostaglandins (a chemical messenger) or a Foley filled to a moderate volume of fluid. These methods have been found to be equal regarding the risk of cesarean delivery. However, a meta-analysis by our team discovered a trend towards a decreased risk of cesarean when cervical ripening is undertaken with Foleys filled to a high volume of fluid (80cc) compared to those filled to a low volume (30cc).Most Canadian Obstetricians use prostaglandins for cervical ripening. To assess if 80cc Foleys result in a lower risk of cesarean, they need to be compared to the Canadian standard of prostaglandins. Therefore a randomized controlled trial is required.
The Greater-Toronto-Area Obstetric (GTA-OB) Network is a group of hospitals committed to facilitating research and will be the setting for the planned large scale trial. The large scale trial will aim to demonstrate a difference in the rate of cesarean from 38% to 31%, which will require the enrollment of 1442 women. It has been estimated that there are 5,437 women who will meet entry criteria in the GTA-OB network each year, if ½ are approached, 20% will need to consent to complete the trial in 3 years. Therefore, this pilot study will determine if this recruitment rate is potentially achievable and will inform design strategies to ensure its success.
The discovery of a simple, non- pharmacological, cost effective manner of cervical ripening that decreases the risk of cesarean would change clinical practice and significantly improve safety for the 33,000 Canadian women and their babies who undergo cervical ripening each year. This pilot trial is a crucial step towards this discovery.
Objectives:
The primary objective for this pilot trial is to determine the probability that an eligible woman will agree to be randomized into the trial comparing 80cc Foleys to prostaglandins for cervical ripening. This study aims to assess if it is possible to obtain a recruitment rate of 20%.
The secondary objective will be a systematic evaluation of the pilot trial process to guide full-scale study design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostaglandin | Active comparator | Drug: prostaglandin of the clinician's choiceAdministration 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) |
| Foley catheter filled to 80cc | Experimental | Device: Foley catheter filled to 80ccInsertion of a Foley catheter through the cervix and filling to 80cc |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheter filled to 80ccA Foley catheter is inserted through the cervix and filled to 80cc | Device | Foley catheter filled to 80cc |
| prostaglandin of the clinician's choiceAlso: Prostin, CervidilInsertion 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 | Drug | Prostaglandin |
Primary outcome
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
Time frame: 15 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 25222162Berndl 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.
- Background: PubMed 24099451Leduc 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.
- Background: PubMed 22419277Jozwiak 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.
- Background: PubMed 15547534Levy 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.
- Background: PubMed 19232606Kashanian 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.
- Background: PubMed 20502296Delaney 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.
- Background: PubMed 22030144Jozwiak 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.
- Derived from this study: PubMed 36996264de 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.
- Individual participant dataSharing planned: No. There is not currently an IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne ML Berndl, MD MSc principal investigator
Sunnybrook Health Sciences Centre,University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter filled to 80cc and prostaglandin of the clinician's choice in people with Labour; Induced and Pilot Study, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993432, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.