<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/NCT03041220</url>
  </required_header>
  <id_info>
    <org_study_id>24387</org_study_id>
    <nct_id>NCT03041220</nct_id>
  </id_info>
  <brief_title>Best Incision Site for Obese Patients - Low Versus High Transverse</brief_title>
  <official_title>Best Incision Site for Obese Patients - Low Versus High Transverse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective chart review using both out patient and inpatient records of obese patients&#xD;
      (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate&#xD;
      the patient's BMI, their skin incision type at time of c-section, their co-morbidities,&#xD;
      number of previous c-sections and post partum follow up for wound infection, wound separation&#xD;
      and wound breakdown. We will also review operative notes to evaluate blood loss, length of&#xD;
      surgery and complications during surgery. We will obtain maternal characteristics and&#xD;
      information about the pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Past studies have looked primarily at vertical vs low transverse skin incision. There is data&#xD;
      that performing a high transverse skin incision on obese patients leads to better&#xD;
      visualization and less wound infection but there are few studies comparing it directly to low&#xD;
      transverse skin incision.&#xD;
&#xD;
      Retrospective chart review of obese patient's who have had a cesarean section at St Mary's&#xD;
      hospital by either a low or high transverse skin incision between January 1, 2009 - July 31,&#xD;
      2014. We will review charts up to 6 week postpartum.&#xD;
&#xD;
      Pregnancies will be identified through identifing those who have cesarean sections. They will&#xD;
      be narrowed down by those who have BMI of &gt; 30. Maternal prenatal records, postnatal records&#xD;
      and delivery records will be reviewed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI no longer at institution&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Type of skin incision</measure>
    <time_frame>Delivery to 6 weeks postpartum</time_frame>
    <description>Identify which type of skin incision has better outcomes in obese pregnant patients</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>cesarean section</arm_group_label>
    <description>Obese pregnant patients who have had a cesarean section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cesarean section</intervention_name>
    <description>obese patients (BMI of 30 or greater) who have had a cesarean section</description>
    <arm_group_label>cesarean section</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ages between 18 - 45 years, female, and no limitation on ethnic background.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese patients (BMI of 30 or greater) who have had a cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vaginal delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Said, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03041220
org study id: 24387
nct id: NCT03041220
lead sponsor: 
has dmc: No
Retrospective chart review using both out patient and inpatient records of obese patients
      (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate
      the patient's BMI, their skin incision type at time of c-section, their co-morbidities,
      number of previous c-sections and post partum follow up for wound infection, wound separation
      and wound breakdown. We will also review operative notes to evaluate blood loss, length of
      surgery and complications during surgery. We will obtain maternal characteristics and
      information about the pregnancy.
Past studies have looked primarily at vertical vs low transverse skin incision. There is data
      that performing a high transverse skin incision on obese patients leads to better
      visualization and less wound infection but there are few studies comparing it directly to low
      transverse skin incision.

      Retrospective chart review of obese patient's who have had a cesarean section at St Mary's
      hospital by either a low or high transverse skin incision between January 1, 2009 - July 31,
      2014. We will review charts up to 6 week postpartum.

      Pregnancies will be identified through identifing those who have cesarean sections. They will
      be narrowed down by those who have BMI of > 30. Maternal prenatal records, postnatal records
      and delivery records will be reviewed.
observational model: Cohort
time perspective: Retrospective
measure: Type of skin incision
time frame: Delivery to 6 weeks postpartum
description: Identify which type of skin incision has better outcomes in obese pregnant patients
arm group label: cesarean section
description: Obese pregnant patients who have had a cesarean section.
intervention type: Procedure
intervention name: cesarean section
description: obese patients (BMI of 30 or greater) who have had a cesarean section
arm group label: cesarean section
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Heather Said, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Sponsor
sharing ipd: No