<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/NCT01721616</url>
  </required_header>
  <id_info>
    <org_study_id>12-13</org_study_id>
    <nct_id>NCT01721616</nct_id>
  </id_info>
  <brief_title>Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis</brief_title>
  <official_title>A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri, Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri, Kansas City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as&#xD;
      the most frequent post-cesarean delivery complication. This increased morbidity translates&#xD;
      into extended post-partum antibiotic use and prolongation of hospital stay with the&#xD;
      subsequent increase in health care expenses. The current regimen recommended by the American&#xD;
      College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation&#xD;
      cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been&#xD;
      associated with an increased risk of endometritis in post-cesarean section patients.&#xD;
      Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely&#xD;
      covers Ureaplasma and would be an excellent second antibiotic for cesarean section&#xD;
      chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard&#xD;
      chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section&#xD;
      endometritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development of post cesarean endometritis</measure>
    <time_frame>3-4 days while in hospital during post partum period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay length</measure>
    <time_frame>3-4 days while in hospital during post partum period</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Endometritis</condition>
  <arm_group>
    <arm_group_label>Cefazolin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single antibiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cefazolin + Azitrhromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>double antibiotic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <arm_group_label>Cefazolin + Azitrhromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <arm_group_label>Cefazolin</arm_group_label>
    <arm_group_label>Cefazolin + Azitrhromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients between 37 and 42 weeks gestational weeks.&#xD;
&#xD;
          -  Pregnant patients undergoing indicated cesarean section at Truman Medical Center&#xD;
             Hospital July 2012 and July 2014.&#xD;
&#xD;
          -  Pregnant patient that received prenatal care at Truman Medical Center. Hospital Hill,&#xD;
             Samuel Rogers or Swope Parkway health centers at least 1 month prior to the Cesarean&#xD;
             delivery.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to cephalosporins or azithromycin.&#xD;
&#xD;
          -  Refusal to sign consent form.&#xD;
&#xD;
          -  Clinical signs of chorioamnionitis: fever 100.4 F or higher, uterine tenderness,&#xD;
             maternal or fetal tachycardia.&#xD;
&#xD;
          -  Immunocompromised condition: HIV positive with CD4 count below 200, chronic steroid&#xD;
             use, pregestational diabetes, cancer, chemotherapy.&#xD;
&#xD;
          -  Need for emergent cesarean precluding consent or availability of study medication.&#xD;
&#xD;
          -  Need for hysterectomy at cesarean section.&#xD;
&#xD;
          -  Use of antibiotic in the 72 hours prior to admission.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro Morales, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri, Kansas City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine Goodpasture, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri, Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Truman Medical Center - Hospital Hill</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>May 4, 2015</last_update_submitted>
  <last_update_submitted_qc>May 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri, Kansas City</investigator_affiliation>
    <investigator_full_name>Pedro Morales-Ramirez</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Cefazolin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01721616
org study id: 12-13
nct id: NCT01721616
lead sponsor: 
has dmc: No
Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as
      the most frequent post-cesarean delivery complication. This increased morbidity translates
      into extended post-partum antibiotic use and prolongation of hospital stay with the
      subsequent increase in health care expenses. The current regimen recommended by the American
      College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation
      cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been
      associated with an increased risk of endometritis in post-cesarean section patients.
      Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely
      covers Ureaplasma and would be an excellent second antibiotic for cesarean section
      chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard
      chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section
      endometritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Development of post cesarean endometritis
time frame: 3-4 days while in hospital during post partum period
measure: Hospital stay length
time frame: 3-4 days while in hospital during post partum period
arm group label: Cefazolin
arm group type: Active Comparator
description: single antibiotic
arm group label: Cefazolin + Azitrhromycin
arm group type: Active Comparator
description: double antibiotic
intervention type: Drug
intervention name: Azithromycin
arm group label: Cefazolin + Azitrhromycin
intervention type: Drug
intervention name: Cefazolin
arm group label: Cefazolin
arm group label: Cefazolin + Azitrhromycin
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pedro Morales, MD
role: Principal Investigator
affiliation: University of Missouri, Kansas City
last name: Katherine Goodpasture, DO
role: Principal Investigator
affiliation: University of Missouri, Kansas City
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri, Kansas City
investigator full name: Pedro Morales-Ramirez
investigator title: MD
mesh term: Endometritis
mesh term: Azithromycin
mesh term: Cefazolin