<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993432</url>
  </required_header>
  <id_info>
    <org_study_id>SHS-16-002</org_study_id>
    <nct_id>NCT02993432</nct_id>
  </id_info>
  <brief_title>High Volume Foleys Increasing Vaginal Birth Pilot Trial</brief_title>
  <official_title>High Volume Foleys Increasing Vaginal Birth (High FIVe Birth) Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AFP Innovation Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is currently unknown if there is a way to decrease the risk of cesarean delivery when&#xD;
      undergoing cervical ripening and induction of labour. Some research suggests a Foley catheter&#xD;
      placed through the cervix and filled to 80cc may decrease this risk. We wish to run a large&#xD;
      scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section compared to&#xD;
      the commonly used medication for cervical ripening, prostaglandins. Before we can undertake a&#xD;
      large trial, we need to do a pilot to see if women will agree to participate in this type of&#xD;
      study. As well, a pilot will help with trouble shooting prior to a large trail, to improve&#xD;
      the chances of successfully answering this clinically important question.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Approximately 1/3 of first-time mothers (nulliparous women) undergoing induction of labour&#xD;
      deliver by cesarean. Cesarean delivery can have negative consequences to the initial and&#xD;
      subsequent pregnancies. Women who have a cesarean in their first pregnancy are more likely to&#xD;
      have a cesarean in their following pregnancies and this group is the largest contributor to&#xD;
      the overall cesarean delivery rate. Therefore, targeting interventions that prevent cesareans&#xD;
      in nulliparous women undergoing induction of labour will have a substantial impact on the&#xD;
      overall cesarean delivery rate.&#xD;
&#xD;
      Adequate ripening or preparing the cervix before induction has been found to decrease the&#xD;
      risk of cesarean. This can be done by a variety of methods, such as prostaglandins (a&#xD;
      chemical messenger) or a Foley filled to a moderate volume of fluid. These methods have been&#xD;
      found to be equal regarding the risk of cesarean delivery. However, a meta-analysis by our&#xD;
      team discovered a trend towards a decreased risk of cesarean when cervical ripening is&#xD;
      undertaken with Foleys filled to a high volume of fluid (80cc) compared to those filled to a&#xD;
      low volume (30cc).Most Canadian Obstetricians use prostaglandins for cervical ripening. To&#xD;
      assess if 80cc Foleys result in a lower risk of cesarean, they need to be compared to the&#xD;
      Canadian standard of prostaglandins. Therefore a randomized controlled trial is required.&#xD;
&#xD;
      The Greater-Toronto-Area Obstetric (GTA-OB) Network is a group of hospitals committed to&#xD;
      facilitating research and will be the setting for the planned large scale trial. The large&#xD;
      scale trial will aim to demonstrate a difference in the rate of cesarean from 38% to 31%,&#xD;
      which will require the enrollment of 1442 women. It has been estimated that there are 5,437&#xD;
      women who will meet entry criteria in the GTA-OB network each year, if ½ are approached, 20%&#xD;
      will need to consent to complete the trial in 3 years. Therefore, this pilot study will&#xD;
      determine if this recruitment rate is potentially achievable and will inform design&#xD;
      strategies to ensure its success.&#xD;
&#xD;
      The discovery of a simple, non- pharmacological, cost effective manner of cervical ripening&#xD;
      that decreases the risk of cesarean would change clinical practice and significantly improve&#xD;
      safety for the 33,000 Canadian women and their babies who undergo cervical ripening each&#xD;
      year. This pilot trial is a crucial step towards this discovery.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objective for this pilot trial is to determine the probability that an eligible&#xD;
      woman will agree to be randomized into the trial comparing 80cc Foleys to prostaglandins for&#xD;
      cervical ripening. This study aims to assess if it is possible to obtain a recruitment rate&#xD;
      of 20%.&#xD;
&#xD;
      The secondary objective will be a systematic evaluation of the pilot trial process to guide&#xD;
      full-scale study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>15 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Labour; Induced</condition>
  <condition>Pilot Study</condition>
  <condition>Cervical Ripening</condition>
  <arm_group>
    <arm_group_label>Prostaglandin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foley catheter filled to 80cc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a Foley catheter through the cervix and filling to 80cc</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley catheter filled to 80cc</intervention_name>
    <description>A Foley catheter is inserted through the cervix and filled to 80cc</description>
    <arm_group_label>Foley catheter filled to 80cc</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prostaglandin of the clinician's choice</intervention_name>
    <description>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</description>
    <arm_group_label>Prostaglandin</arm_group_label>
    <other_name>Prostin, Cervidil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous women 37 weeks and 0 days to 41 weeks and 6 days gestational age (term)&#xD;
             requiring cervical ripening&#xD;
&#xD;
          -  Health care provider feels it is possible to administer either method of cervical&#xD;
             ripening.&#xD;
&#xD;
          -  Bishop score of 6 or less&#xD;
&#xD;
          -  Live, singleton, cephalic fetus&#xD;
&#xD;
          -  Availability of personnel to consent and randomize participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-viable fetus&#xD;
&#xD;
          -  Contraindication to cervical ripening, labour induction or labour&#xD;
&#xD;
          -  Prior attempt at induction of labour in this pregnancy&#xD;
&#xD;
          -  Spontaneous rupture of fetal membranes&#xD;
&#xD;
          -  Evidence of labour or regular uterine contractions&#xD;
&#xD;
          -  Lack of consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne ML Berndl, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre,University of Toronto</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>25222162</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24099451</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22419277</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/j.ajog.2004.03.033.</citation>
    <PMID>15547534</PMID>
  </reference>
  <reference>
    <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. No abstract available.</citation>
    <PMID>19232606</PMID>
  </reference>
  <reference>
    <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):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.</citation>
    <PMID>20502296</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22030144</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Anne Berndl</investigator_full_name>
    <investigator_title>Assistant Professor University of Toronto Division of Maternal Fetal Medicine Department of Obstetrics and Gynaecology, Associate Scientist, Sunnybrook Research Institute</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not currently an IPD sharing plan</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT02993432/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993432
org study id: SHS-16-002
nct id: NCT02993432
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
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
description: 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.
arm group label: Prostaglandin
arm group type: Active Comparator
description: 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)
arm group label: Foley catheter filled to 80cc
arm group type: Experimental
description: Insertion of a Foley catheter through the cervix and filling to 80cc
intervention type: Device
intervention name: Foley catheter filled to 80cc
description: A Foley catheter is inserted through the cervix and filled to 80cc
arm group label: Foley catheter filled to 80cc
intervention type: Drug
intervention name: prostaglandin of the clinician's choice
description: 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
arm group label: Prostaglandin
other name: Prostin, Cervidil
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne ML Berndl, MD MSc
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre,University of Toronto
citation: 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
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.
PMID: 24099451
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.
PMID: 22419277
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. doi: 10.1016/j.ajog.2004.03.033.
PMID: 15547534
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. No abstract available.
PMID: 19232606
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):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.
PMID: 20502296
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.
PMID: 22030144
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Anne Berndl
investigator title: Assistant Professor University of Toronto Division of Maternal Fetal Medicine Department of Obstetrics and Gynaecology, Associate Scientist, Sunnybrook Research Institute
sharing ipd: No
ipd description: There is not currently an IPD sharing plan
provided document: 