<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/NCT03026647</url>
  </required_header>
  <id_info>
    <org_study_id>27509</org_study_id>
    <nct_id>NCT03026647</nct_id>
  </id_info>
  <brief_title>Suture Material for Closure of Hysterotomy</brief_title>
  <official_title>Evaluation of Suture Material for Closure of Hysterotomy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective chart review evaluating different suture types on surgical outcomes for&#xD;
      cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures&#xD;
      are used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cesarean sections are one of the most common surgeries performed in the United States;&#xD;
      approximately 1 out of 3 births are completed by cesarean delivery. In 2014, 1,284,551&#xD;
      cesarean deliveries were performed. Unfortunately, even with this being a very common&#xD;
      procedure some surgical topics have not been fully evaluated. One of these topics is the&#xD;
      choice of suture for repair of the hysterotomy (uterine) incision. Several suture materials&#xD;
      are available, yet only polygatactin-910 and catgut have been evaluated in a single study. In&#xD;
      this study, only surgery complications were evaluated. Catgut was found to be associated with&#xD;
      less risk of receiving a blood transfusion, otherwise no differences were found. One of the&#xD;
      most common suture materials used at our institution is poliglecaprone 25, however no long&#xD;
      term studies have been completed for this indication. In addition, no studies have evaluated&#xD;
      the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25&#xD;
      to repair the hysterotomy. This information could be very useful in counseling for patients.&#xD;
      As the cesarean delivery rates continue to climb, information on appropriate technique for&#xD;
      surgery are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not moving forward staff shortage&#xD;
  </why_stopped>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>Preferred suture</measure>
    <time_frame>3 months</time_frame>
    <description>Preferred suture chart review</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Cesarean Section; Complications, Wound, Hematoma</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suture</intervention_name>
    <description>To examine different types of suture material used for hysterotomy closure in cesarean section and determine if one is preferred above other types due to a complications profile.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female, pregnant, All ethnic backgrounds,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who underwent a cesarean delivery or vaginal birth after cesarean&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Goldkamp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Jennifer Goldkamp, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma</mesh_term>
  </condition_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/NCT03026647
org study id: 27509
nct id: NCT03026647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective chart review evaluating different suture types on surgical outcomes for
      cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures
      are used.
Cesarean sections are one of the most common surgeries performed in the United States;
      approximately 1 out of 3 births are completed by cesarean delivery. In 2014, 1,284,551
      cesarean deliveries were performed. Unfortunately, even with this being a very common
      procedure some surgical topics have not been fully evaluated. One of these topics is the
      choice of suture for repair of the hysterotomy (uterine) incision. Several suture materials
      are available, yet only polygatactin-910 and catgut have been evaluated in a single study. In
      this study, only surgery complications were evaluated. Catgut was found to be associated with
      less risk of receiving a blood transfusion, otherwise no differences were found. One of the
      most common suture materials used at our institution is poliglecaprone 25, however no long
      term studies have been completed for this indication. In addition, no studies have evaluated
      the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25
      to repair the hysterotomy. This information could be very useful in counseling for patients.
      As the cesarean delivery rates continue to climb, information on appropriate technique for
      surgery are needed.
observational model: Cohort
time perspective: Retrospective
measure: Preferred suture
time frame: 3 months
description: Preferred suture chart review
intervention type: Procedure
intervention name: Suture
description: To examine different types of suture material used for hysterotomy closure in cesarean section and determine if one is preferred above other types due to a complications profile.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
last name: Jennifer Goldkamp, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Jennifer Goldkamp, MD
investigator title: Principal Investigator
mesh term: Hematoma
sharing ipd: No