<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/NCT04452747</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL19_0044</org_study_id>
    <secondary_id>7756</secondary_id>
    <nct_id>NCT04452747</nct_id>
  </id_info>
  <brief_title>Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies</brief_title>
  <acronym>BESTWAY</acronym>
  <official_title>Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Labour induction is an obstetrical procedure, which artificially starts the process of cervix&#xD;
      dilation, in order to induce labour. Several methods of labour induction exist : mechanical&#xD;
      ones (using dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin).&#xD;
      This trial aims to compare, in case of non-favourable cervix, the strategy of labour&#xD;
      induction using the Propess® method first (Dino-first) versus the strategy beginning with the&#xD;
      use of a dilatation balloon (Ballon-first), with respect of the usual practice and the&#xD;
      current guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Actual">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">October 2, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of vaginal deliveries</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Rate of vaginal deliveries (both spontaneous or instrumentally assisted)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of spontaneous vaginal deliveries</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of spontaneous vaginal deliveries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of instrumentally assisted vaginal deliveries, including the reason for the assistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of C-section including the reason for the C-section</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of C-section including the reason for the C-section. The reasons for the C-section can be : a failure of dilatation at the first stage of the labour (between 0 and 10 cm), an absence of foetal descent at the second stage of labour, a foetal reason or a maternal reason)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeframe between the beginning of the induction and the beginning of the labour</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Time elapsed between the beginning of the induction and the beginning of the labour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulated rate of spontaneous vaginal deliveries</measure>
    <time_frame>at 12 hours, 24 hours and 48 hours</time_frame>
    <description>Cumulated number of spontaneous vaginal deliveries at 12 hours, 24 hours and 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of labour induction failure</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Rate of labour induction failure is measure by the number of C-sections carried out due to a latency phase (0-6cm), which lasted more than 24 hours, together with the administration of oxytocin for at least 12 to 18 hours after the membranes artifically broke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of peridural anaesthesia during labour</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of peridural anaesthesia during labour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of uterine hyperstimulation without impact on the foetus</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of uterine hyperstimulation with an impact on the foetus</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of uterine hypertonia</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Uterine hypertonia is describes as a frequency of contractions every 2 minutes or less together with a slowing of the foetal heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of post-partum haemorrhagia</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Rate of post-partum haemorrhagia above 500 mL, above 1000 mL, transfusion level and number of packed red blood cells transfused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of uterine rupture</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of patients with a uterine rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of intra-uterine infections</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of patients with intra-uterine infections (body temperature above 38°C measured twice within 30 minutes, associated to 2 criteria within the followings: foetal tachycardia above 160 beats per minute, pain of the uterus or painful uterus contractions ou spontaneous labour induction, or purulent amniotic fluid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of post-partum infections</measure>
    <time_frame>One week after day of the delivery</time_frame>
    <description>Number of patients with post-partum infections (body temperature above 38°C with antibiotic treatment, urinary tract infections, bacteriological endometritis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of neonatal asphyxia</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of fetuses with neonatal asphyxia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of hospitalization in Neonatal intensive care unit</measure>
    <time_frame>Up to four days after the delivery</time_frame>
    <description>Number of newborn babies hospitalized in Neonatal intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of proven bacteriological infections in newborn babies</measure>
    <time_frame>Up to four days after the delivery</time_frame>
    <description>Number of proven bacteriological infections in newborn babies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Number of women who experienced metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Measurement of Pain will be made using an Visual Analog Scale (VAS). The pain level will be linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level recorded at different times of the labour induction</measure>
    <time_frame>On the day of the delivery</time_frame>
    <description>Measurement will be made using a Visual Analog Scale (VAS) and will be recorded at different times of the dilatation balloon or the dinoprostone vaginal pad set up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the patient experience of the labour induction</measure>
    <time_frame>Up to two weeks after the delivery</time_frame>
    <description>Patient experience will be assessed using the W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of each strategy direct main costs</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>The costs of the treatment and duration of the hospitalization will be measured</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Dino-first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balloon-first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Labour will be induced by the use of a cervix dilatation balloon first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal Dinoprostone system (Propess®)</intervention_name>
    <description>Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy</description>
    <arm_group_label>Dino-first</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dilatation balloon</intervention_name>
    <description>Labour will be induced using a cervix dilatation balloon as a first strategy</description>
    <arm_group_label>Balloon-first</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with singleton pregnancy&#xD;
&#xD;
          -  Fetus with cephalic presentation&#xD;
&#xD;
          -  Intact membranes between 37 and 42 weeks of amenorrhea&#xD;
&#xD;
          -  Medical indication for labour induction according to the &quot;Haute Autorité de Santé&quot;&#xD;
             (HAS) guidelines&#xD;
&#xD;
          -  Unfavourable cervix (Bishop scoring &lt; 7)&#xD;
&#xD;
          -  Age &gt; 18 years-old&#xD;
&#xD;
          -  Person affiliated to a healthcare system&#xD;
&#xD;
          -  Good understanding of the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous C-section or uterine incision&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  Metrorrhagia of unknown origin&#xD;
&#xD;
          -  Lethal foetal abnormality&#xD;
&#xD;
          -  Hyperreactivity to one of the molecules used for the induction (dinoprostone or&#xD;
             oxytocin) or to latex&#xD;
&#xD;
          -  Subject participants to another biomedical research&#xD;
&#xD;
          -  Subject under legal guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florent FUCHS, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>UH of Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nimes University Hospital</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dinoprostone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04452747
org study id: RECHMPL19_0044
secondary id: 7756
nct id: NCT04452747
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Labour induction is an obstetrical procedure, which artificially starts the process of cervix
      dilation, in order to induce labour. Several methods of labour induction exist : mechanical
      ones (using dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin).
      This trial aims to compare, in case of non-favourable cervix, the strategy of labour
      induction using the Propess® method first (Dino-first) versus the strategy beginning with the
      use of a dilatation balloon (Ballon-first), with respect of the usual practice and the
      current guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of vaginal deliveries
time frame: On the day of the delivery
description: Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
measure: Rate of spontaneous vaginal deliveries
time frame: On the day of the delivery
description: Number of spontaneous vaginal deliveries
measure: Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance
time frame: On the day of the delivery
description: Number of instrumentally assisted vaginal deliveries, including the reason for the assistance
measure: Rate of C-section including the reason for the C-section
time frame: On the day of the delivery
description: Number of C-section including the reason for the C-section. The reasons for the C-section can be : a failure of dilatation at the first stage of the labour (between 0 and 10 cm), an absence of foetal descent at the second stage of labour, a foetal reason or a maternal reason)
measure: Timeframe between the beginning of the induction and the beginning of the labour
time frame: On the day of the delivery
description: Time elapsed between the beginning of the induction and the beginning of the labour
measure: Cumulated rate of spontaneous vaginal deliveries
time frame: at 12 hours, 24 hours and 48 hours
description: Cumulated number of spontaneous vaginal deliveries at 12 hours, 24 hours and 48 hours
measure: Rate of labour induction failure
time frame: On the day of the delivery
description: Rate of labour induction failure is measure by the number of C-sections carried out due to a latency phase (0-6cm), which lasted more than 24 hours, together with the administration of oxytocin for at least 12 to 18 hours after the membranes artifically broke.
measure: Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
time frame: On the day of the delivery
description: Number of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin
measure: Rate of peridural anaesthesia during labour
time frame: On the day of the delivery
description: Number of peridural anaesthesia during labour
measure: Rate of uterine hyperstimulation without impact on the foetus
time frame: On the day of the delivery
description: Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.
measure: Rate of uterine hyperstimulation with an impact on the foetus
time frame: On the day of the delivery
description: Uterine hyperstimulation is described as a number of contractions of 6 or more within 10 minutes, repeating at least twice). Foetal impact is defined as a slowing of the foetal heart rate.
measure: Rate of uterine hypertonia
time frame: On the day of the delivery
description: Uterine hypertonia is describes as a frequency of contractions every 2 minutes or less together with a slowing of the foetal heart rate.
measure: Rate of post-partum haemorrhagia
time frame: On the day of the delivery
description: Rate of post-partum haemorrhagia above 500 mL, above 1000 mL, transfusion level and number of packed red blood cells transfused
measure: Rate of uterine rupture
time frame: On the day of the delivery
description: Number of patients with a uterine rupture
measure: Rate of intra-uterine infections
time frame: On the day of the delivery
description: Number of patients with intra-uterine infections (body temperature above 38°C measured twice within 30 minutes, associated to 2 criteria within the followings: foetal tachycardia above 160 beats per minute, pain of the uterus or painful uterus contractions ou spontaneous labour induction, or purulent amniotic fluid.
measure: Rate of post-partum infections
time frame: One week after day of the delivery
description: Number of patients with post-partum infections (body temperature above 38°C with antibiotic treatment, urinary tract infections, bacteriological endometritis)
measure: Rate of neonatal asphyxia
time frame: On the day of the delivery
description: Number of fetuses with neonatal asphyxia
measure: Rate of hospitalization in Neonatal intensive care unit
time frame: Up to four days after the delivery
description: Number of newborn babies hospitalized in Neonatal intensive care unit
measure: Rate of proven bacteriological infections in newborn babies
time frame: Up to four days after the delivery
description: Number of proven bacteriological infections in newborn babies
measure: Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
time frame: On the day of the delivery
description: Number of women who experienced metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)
measure: Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
time frame: On the day of the delivery
description: Measurement of Pain will be made using an Visual Analog Scale (VAS). The pain level will be linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon
measure: Pain level recorded at different times of the labour induction
time frame: On the day of the delivery
description: Measurement will be made using a Visual Analog Scale (VAS) and will be recorded at different times of the dilatation balloon or the dinoprostone vaginal pad set up
measure: Assessment of the patient experience of the labour induction
time frame: Up to two weeks after the delivery
description: Patient experience will be assessed using the W-DEQ (Wijma Delivery Expectancy/Experience Questionnaire)
measure: Assessment of each strategy direct main costs
time frame: through study completion, an average of 3 years
description: The costs of the treatment and duration of the hospitalization will be measured
arm group label: Dino-first
arm group type: Active Comparator
description: Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.
arm group label: Balloon-first
arm group type: Active Comparator
description: Labour will be induced by the use of a cervix dilatation balloon first.
intervention type: Procedure
intervention name: Vaginal Dinoprostone system (Propess®)
description: Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
arm group label: Dino-first
intervention type: Procedure
intervention name: Dilatation balloon
description: Labour will be induced using a cervix dilatation balloon as a first strategy
arm group label: Balloon-first
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florent FUCHS, MD PhD
role: Study Director
affiliation: UH of Montpellier
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Dinoprostone
sharing ipd: No