<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/NCT03024632</url>
  </required_header>
  <id_info>
    <org_study_id>27685</org_study_id>
    <nct_id>NCT03024632</nct_id>
  </id_info>
  <brief_title>Previous Cesarean Sections</brief_title>
  <official_title>Trial of Labor After 3 or More Previous Cesarean Sections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective chart review. The purpose is to look at the outcomes for women and&#xD;
      newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2006, the vaginal birth after cesarean (VBAC) rate was 8.5%, compared to a rate of 28.3%&#xD;
      in 1996. This was also associated with a rise in the rate of cesarean section from&#xD;
      approximately 20% to 31.1% over that same period of time. In that 10 year period, some&#xD;
      hospitals stopped offering a trial of labor after cesarean (TOLAC) altogether.&#xD;
&#xD;
      Currently, the American College of Obstetricians and Gynecologists states in Practice&#xD;
      Bulletin 115 (2010), Vaginal Birth After Previous Cesarean Delivery, &quot;it is reasonable to&#xD;
      consider women with 2 previous low transverse cesarean deliveries to be candidates for&#xD;
      TOLAC…Data regarding the risk for women undergoing TOLAC with more than two previous cesarean&#xD;
      deliveries is limited.&quot;&#xD;
&#xD;
      In 1994, a study reviewing10 years of data regarding trial of labor after cesarean. Of their&#xD;
      population with 3 or more previous cesarean deliveries, 30% of patients underwent a trial of&#xD;
      labor, with a 79% success rate. In this group, the uterine rupture rate was 1.2% with zero&#xD;
      perinatal deaths related to rupture, which is compared to a rupture rate of 1.8% and 1&#xD;
      perinatal death in the group of 2 previous cesarean deliveries.&#xD;
&#xD;
      In 2002, another study described the outcomes of women who underwent a trial of labor after 2&#xD;
      or more previous cesarean deliveries at two large university hospitals in the Netherlands,&#xD;
      but it included just 59 patients total and only 4 of these had 3 previous cesarean&#xD;
      deliveries. No patients with more than 3 previous cesarean deliveries had a trial of labor.&#xD;
&#xD;
      A study in 2010, described a large cohort of women from the northeastern United States with 3&#xD;
      or more previous cesarean deliveries, including those attempting VBAC. This cohort included&#xD;
      89 women, of whom 79.8% had a successful VBAC. However, of the women who had a TOLAC, 40.4%&#xD;
      delivered in a university hospital and only 18.0% in a hospital with an OB/GYN residency,&#xD;
      compared to 56.9% and 25.4% of women who had an elective repeat cesarean section. In the&#xD;
      group that had a TOLAC, there were no cases of uterine rupture.&#xD;
&#xD;
      There still remains a lack of data about the outcomes of the delivery of women who desire a&#xD;
      trial of labor after 3 or more previous cesarean deliveries at a single institution.&#xD;
&#xD;
      The investigators will analyze and compare the management and outcomes of women and neonates&#xD;
      for patients who attempted a trial of labor after 3 or more previous cesareans. We will also&#xD;
      compare them to women and neonates of patients who underwent a repeat cesarean section&#xD;
      without a trial of labor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Closed study. Study is retrospective in nature and never enrolled any subjects.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Vaginal births</measure>
    <time_frame>Labor through 6 weeks postpartum</time_frame>
    <description>outcomes and safety of a trial of labor after 3 or more previous c-sections managed at a tertiary care facility</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>trial of labor</arm_group_label>
    <description>Pregnant women with a history of 3 or more cesarean sections who desired a trial of labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No trial of labor</arm_group_label>
    <description>Pregnant women with a history of 3 or more cesarean sections who desired a a repeat cesarean section</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trial of labor</intervention_name>
    <description>trial of labor after 3 or more previous cesarean deliveries</description>
    <arm_group_label>trial of labor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        14-55yrs of age Pregnant all ethnic backgrounds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with a history of 3 or more cesarean sections&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  singleton&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 3 cesarean sections&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Q Buchanan, MD</last_name>
    <role>Study Director</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Christopher Buchanan, MD</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03024632
org study id: 27685
nct id: NCT03024632
lead sponsor: 
has dmc: No
This is a retrospective chart review. The purpose is to look at the outcomes for women and
      newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.
In 2006, the vaginal birth after cesarean (VBAC) rate was 8.5%, compared to a rate of 28.3%
      in 1996. This was also associated with a rise in the rate of cesarean section from
      approximately 20% to 31.1% over that same period of time. In that 10 year period, some
      hospitals stopped offering a trial of labor after cesarean (TOLAC) altogether.

      Currently, the American College of Obstetricians and Gynecologists states in Practice
      Bulletin 115 (2010), Vaginal Birth After Previous Cesarean Delivery, "it is reasonable to
      consider women with 2 previous low transverse cesarean deliveries to be candidates for
      TOLAC…Data regarding the risk for women undergoing TOLAC with more than two previous cesarean
      deliveries is limited."

      In 1994, a study reviewing10 years of data regarding trial of labor after cesarean. Of their
      population with 3 or more previous cesarean deliveries, 30% of patients underwent a trial of
      labor, with a 79% success rate. In this group, the uterine rupture rate was 1.2% with zero
      perinatal deaths related to rupture, which is compared to a rupture rate of 1.8% and 1
      perinatal death in the group of 2 previous cesarean deliveries.

      In 2002, another study described the outcomes of women who underwent a trial of labor after 2
      or more previous cesarean deliveries at two large university hospitals in the Netherlands,
      but it included just 59 patients total and only 4 of these had 3 previous cesarean
      deliveries. No patients with more than 3 previous cesarean deliveries had a trial of labor.

      A study in 2010, described a large cohort of women from the northeastern United States with 3
      or more previous cesarean deliveries, including those attempting VBAC. This cohort included
      89 women, of whom 79.8% had a successful VBAC. However, of the women who had a TOLAC, 40.4%
      delivered in a university hospital and only 18.0% in a hospital with an OB/GYN residency,
      compared to 56.9% and 25.4% of women who had an elective repeat cesarean section. In the
      group that had a TOLAC, there were no cases of uterine rupture.

      There still remains a lack of data about the outcomes of the delivery of women who desire a
      trial of labor after 3 or more previous cesarean deliveries at a single institution.

      The investigators will analyze and compare the management and outcomes of women and neonates
      for patients who attempted a trial of labor after 3 or more previous cesareans. We will also
      compare them to women and neonates of patients who underwent a repeat cesarean section
      without a trial of labor.
observational model: Cohort
time perspective: Retrospective
measure: Number of Vaginal births
time frame: Labor through 6 weeks postpartum
description: outcomes and safety of a trial of labor after 3 or more previous c-sections managed at a tertiary care facility
arm group label: trial of labor
description: Pregnant women with a history of 3 or more cesarean sections who desired a trial of labor
arm group label: No trial of labor
description: Pregnant women with a history of 3 or more cesarean sections who desired a a repeat cesarean section
intervention type: Procedure
intervention name: Trial of labor
description: trial of labor after 3 or more previous cesarean deliveries
arm group label: trial of labor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Christopher Q Buchanan, MD
role: Study Director
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Christopher Buchanan, MD
investigator title: Principal Investigator
sharing ipd: No