<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/NCT03298594</url>
  </required_header>
  <id_info>
    <org_study_id>12-173 MATPED 12-036</org_study_id>
    <nct_id>NCT03298594</nct_id>
  </id_info>
  <brief_title>A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section</brief_title>
  <official_title>A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The main objective is to evaluate a specific cervicograph (the graph describing the cervical&#xD;
      dilation, included in the partograph) for pregnant women with an history of cesarean section,&#xD;
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women&#xD;
      will be randomly assigned to this specific cervicograph (including an action line 2 hours&#xD;
      after the alert line), or to the normal cervicograph (no lines). The primary outcome is&#xD;
      appropriate detection of dystocia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Appropriate management of labor is essential to minimize the risk of uterine rupture in case&#xD;
      of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk&#xD;
      factor for uterine rupture during labor in women with previous cesarean section. Some studies&#xD;
      have shown that this risk increases after 2 hours at the same cervical dilation during labor.&#xD;
      The cervicograph is an important tool to detect dystocia during labor. There is currently no&#xD;
      specific cervicograph for pregnant women with a history of cesarean section, and no study&#xD;
      evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.&#xD;
&#xD;
      The main objective is to evaluate a specific cervicograph (the graph describing the cervical&#xD;
      dilation, included in the partograph) for pregnant women with an history of cesarean section,&#xD;
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women&#xD;
      will be randomly assigned to a specific cervicograph (including an action line 2 hours after&#xD;
      the alert line), or to the normal cervicograph (no lines).&#xD;
&#xD;
      The outcomes of this randomized trial are: appropriate detection and management of dystocia;&#xD;
      uterine rupture; and success of VBAC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2013</start_date>
  <completion_date type="Actual">October 11, 2016</completion_date>
  <primary_completion_date type="Actual">October 11, 2016</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The cervicograph of all participants will be reviewed by two assessors blinded to the study group. In order to be blinded, lines will be added to the cervicographs of the control group by a third party not involved in the evaluation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of dystocia during labor in women with past history of cesarean section</measure>
    <time_frame>From inclusion in the study (randomization usually from 2cm) until full cervical dilation.</time_frame>
    <description>Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uterine rupture during labor in women with past history of cesarean section</measure>
    <time_frame>From inclusion in the study (randomization usually from 2cm) until delivery</time_frame>
    <description>Uterine rupture will be defined as a complete separation of the uterine scar that resulted in protrusion of fetal or placental parts in the peritoneal cavity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of VBAC</measure>
    <time_frame>at delivery</time_frame>
    <description>Percentage of vaginal delivery in women with past history of cesarean section</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Attempted Vaginal Delivery After a Cesarean Section</condition>
  <arm_group>
    <arm_group_label>specific cervicograph</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual cervicograph</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual cervicograph in our unit is not having lines</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>specific cervicograph</intervention_name>
    <arm_group_label>specific cervicograph</arm_group_label>
    <other_name>usual cervicograph</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more&#xD;
&#xD;
          -  Single pregnancy&#xD;
&#xD;
          -  Cephalic presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 1 previous cesarean section&#xD;
&#xD;
          -  Multiple pregnancies&#xD;
&#xD;
          -  Presentations other than cephalic&#xD;
&#xD;
          -  History of low vertical uterotomy, classical or inverted T-shaped&#xD;
&#xD;
          -  Past history of myomectomy&#xD;
&#xD;
          -  Fetal death&#xD;
&#xD;
          -  Fetal anomalies&#xD;
&#xD;
          -  Placental anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Michel Boulvain</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <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/NCT03298594
org study id: 12-173 MATPED 12-036
nct id: NCT03298594
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective is to evaluate a specific cervicograph (the graph describing the cervical
      dilation, included in the partograph) for pregnant women with an history of cesarean section,
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women
      will be randomly assigned to this specific cervicograph (including an action line 2 hours
      after the alert line), or to the normal cervicograph (no lines). The primary outcome is
      appropriate detection of dystocia.
Appropriate management of labor is essential to minimize the risk of uterine rupture in case
      of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk
      factor for uterine rupture during labor in women with previous cesarean section. Some studies
      have shown that this risk increases after 2 hours at the same cervical dilation during labor.
      The cervicograph is an important tool to detect dystocia during labor. There is currently no
      specific cervicograph for pregnant women with a history of cesarean section, and no study
      evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.

      The main objective is to evaluate a specific cervicograph (the graph describing the cervical
      dilation, included in the partograph) for pregnant women with an history of cesarean section,
      to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women
      will be randomly assigned to a specific cervicograph (including an action line 2 hours after
      the alert line), or to the normal cervicograph (no lines).

      The outcomes of this randomized trial are: appropriate detection and management of dystocia;
      uterine rupture; and success of VBAC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: The cervicograph of all participants will be reviewed by two assessors blinded to the study group. In order to be blinded, lines will be added to the cervicographs of the control group by a third party not involved in the evaluation
measure: Detection of dystocia during labor in women with past history of cesarean section
time frame: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.
description: Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.
measure: Uterine rupture during labor in women with past history of cesarean section
time frame: From inclusion in the study (randomization usually from 2cm) until delivery
description: Uterine rupture will be defined as a complete separation of the uterine scar that resulted in protrusion of fetal or placental parts in the peritoneal cavity
measure: Percentage of VBAC
time frame: at delivery
description: Percentage of vaginal delivery in women with past history of cesarean section
arm group label: specific cervicograph
arm group type: Experimental
description: Specific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor
arm group label: Usual cervicograph
arm group type: No Intervention
description: The usual cervicograph in our unit is not having lines
intervention type: Diagnostic Test
intervention name: specific cervicograph
arm group label: specific cervicograph
other name: usual cervicograph
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Michel Boulvain
investigator title: MD, PhD
sharing ipd: No