<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/NCT03248297</url>
  </required_header>
  <id_info>
    <org_study_id>CHI UAB MISP # 54628</org_study_id>
    <nct_id>NCT03248297</nct_id>
  </id_info>
  <brief_title>Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries</brief_title>
  <official_title>Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,&#xD;
      Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or&#xD;
      prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of&#xD;
      azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal&#xD;
      infectious outcomes and perinatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This 3-arm study is a large randomized clinical trial designed to evaluate the comparative&#xD;
      effectiveness and safety of single dose oral azithromycin or combined&#xD;
      azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and&#xD;
      sepsis in laboring women. We have previously shown the effectiveness of azithromycin for&#xD;
      extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for&#xD;
      reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis&#xD;
      from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at&#xD;
      reducing these morbidities in women who have vaginal births. There is an increased risk of&#xD;
      infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from&#xD;
      our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery,&#xD;
      we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or&#xD;
      without oral amoxicillin) to prevent maternal peripartum infection and sepsis. This study,&#xD;
      performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will&#xD;
      randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor&#xD;
      ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin,&#xD;
      compared to usual care (placebo). Women will be followed to ascertain maternal infectious&#xD;
      outcomes and perinatal outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Composite Peripartum Infection or Death</measure>
    <time_frame>Up to 6 weeks after delivery</time_frame>
    <description>Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Pyelonephritis</measure>
    <time_frame>Up to hospital discharge</time_frame>
    <description>Other Infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Breast Infection</measure>
    <time_frame>Up to 6 weeks after delivery</time_frame>
    <description>Other infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Other Infection</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Fever</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Any fever higher than 38C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Hypothermia</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Any hypothermia less than 36C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Needed PP Antibiotic</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Any postpartum antibiotic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Transfusion</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Stillbirth</measure>
    <time_frame>delivery</time_frame>
    <description>Any stillbirth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>up to 6 weeks postpartum</time_frame>
    <description>Length of stay in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced a Clinic Visit</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Clinic visit after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced a Maternal Readmission</measure>
    <time_frame>up to 6 weeks after delivery</time_frame>
    <description>Maternal readmission</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">756</enrollment>
  <condition>Postpartum Sepsis</condition>
  <condition>Postpartum Endometritis</condition>
  <condition>Postpartum Fever</condition>
  <arm_group>
    <arm_group_label>Azithromycin and amoxicillin placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Azithromycin + amoxicillin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Azithromycin tablet</description>
    <arm_group_label>Azithromycin and amoxicillin placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin and amoxicillin</intervention_name>
    <description>azithromycin and amoxicillin</description>
    <arm_group_label>Azithromycin + amoxicillin</arm_group_label>
    <other_name>azithromycin, amoxicillin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet</description>
    <arm_group_label>Azithromycin and amoxicillin placebo</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal&#xD;
             delivery with&#xD;
&#xD;
               1. Prolonged membrane rupture (≥8 hours) or&#xD;
&#xD;
               2. Prolonged labor (≥18 hours).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical chorioamnionitis or any other active bacterial infection (e.g.&#xD;
             pyelonephritis, pneumonia, abscess) at time of randomization: because standard&#xD;
             antibiotic therapy for these conditions may confound trial intervention.&#xD;
&#xD;
          -  Allergy to azithromycin or amoxicillin&#xD;
&#xD;
          -  Plan for cesarean delivery prior to enrollment&#xD;
&#xD;
          -  Fetal demise or major congenital anomaly: Major congenital anomalies may confound&#xD;
             assessment of neonatal outcomes and every attempt will be made up front to exclude&#xD;
             them from randomization. However, some unrecognized fetal anomalies may inevitably be&#xD;
             randomized. These will not be excluded post-randomization from the primary (maternal&#xD;
             outcome) analysis; they will be taken into consideration in the secondary analyses of&#xD;
             neonatal outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Tita, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cameroon Baptist Convention Health Services</name>
      <address>
        <city>Bamenda</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
  </location_countries>
  <reference>
    <citation>Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.</citation>
    <PMID>10196487</PMID>
  </reference>
  <reference>
    <citation>ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm. 1999 Sep 15;56(18):1839-88. doi: 10.1093/ajhp/56.18.1839. No abstract available.</citation>
    <PMID>10511234</PMID>
  </reference>
  <reference>
    <citation>Tita ATN, Boggess K, Saade G. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2017 Jan 12;376(2):182. doi: 10.1056/NEJMc1614626. No abstract available.</citation>
    <PMID>28076707</PMID>
  </reference>
  <reference>
    <citation>WHO. WHO recommendations for prevention and treatment of maternal peripartum infections. Sept 2015 http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines/en/</citation>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>November 16, 2021</results_first_submitted>
  <results_first_submitted_qc>March 18, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2022</results_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Alan Tita</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Puerperal Infection</mesh_term>
    <mesh_term>Endometritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03248297/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Azithromycin and Amoxicillin Placebo</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
        </group>
        <group group_id="P2">
          <title>Azithromycin + Amoxicillin</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
        </group>
        <group group_id="P3">
          <title>Usual Care</title>
          <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="253"/>
                <participants group_id="P2" count="253"/>
                <participants group_id="P3" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="253"/>
                <participants group_id="P2" count="253"/>
                <participants group_id="P3" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Azithromycin and Amoxicillin Placebo</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
        </group>
        <group group_id="B2">
          <title>Azithromycin + Amoxicillin</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
        </group>
        <group group_id="B3">
          <title>Usual Care</title>
          <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="253"/>
            <count group_id="B2" value="253"/>
            <count group_id="B3" value="250"/>
            <count group_id="B4" value="756"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.2" spread="5.3"/>
                    <measurement group_id="B2" value="26.4" spread="5.6"/>
                    <measurement group_id="B3" value="26.0" spread="5.3"/>
                    <measurement group_id="B4" value="26.5" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="253"/>
                    <measurement group_id="B3" value="250"/>
                    <measurement group_id="B4" value="756"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="253"/>
                    <measurement group_id="B3" value="250"/>
                    <measurement group_id="B4" value="756"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="253"/>
                    <measurement group_id="B3" value="250"/>
                    <measurement group_id="B4" value="756"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age at Randomization</title>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.4" spread="1.5"/>
                    <measurement group_id="B2" value="39.2" spread="1.4"/>
                    <measurement group_id="B3" value="39.2" spread="1.4"/>
                    <measurement group_id="B4" value="39.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Composite Peripartum Infection or Death</title>
        <description>Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death</description>
        <time_frame>Up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Composite Peripartum Infection or Death</title>
          <description>Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Pyelonephritis</title>
        <description>Other Infections</description>
        <time_frame>Up to hospital discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Pyelonephritis</title>
          <description>Other Infections</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Breast Infection</title>
        <description>Other infections</description>
        <time_frame>Up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Breast Infection</title>
          <description>Other infections</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Other Infection</title>
        <description>Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Other Infection</title>
          <description>Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Fever</title>
        <description>Any fever higher than 38C</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Fever</title>
          <description>Any fever higher than 38C</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Hypothermia</title>
        <description>Any hypothermia less than 36C</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Hypothermia</title>
          <description>Any hypothermia less than 36C</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Needed PP Antibiotic</title>
        <description>Any postpartum antibiotic</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Needed PP Antibiotic</title>
          <description>Any postpartum antibiotic</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Transfusion</title>
        <description>Blood transfusion</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Transfusion</title>
          <description>Blood transfusion</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Stillbirth</title>
        <description>Any stillbirth</description>
        <time_frame>delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Stillbirth</title>
          <description>Any stillbirth</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay</title>
        <description>Length of stay in days</description>
        <time_frame>up to 6 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay</title>
          <description>Length of stay in days</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.0"/>
                    <measurement group_id="O2" value="3.7" spread="2.2"/>
                    <measurement group_id="O3" value="3.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced a Clinic Visit</title>
        <description>Clinic visit after discharge</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Clinic Visit</title>
          <description>Clinic visit after discharge</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced a Maternal Readmission</title>
        <description>Maternal readmission</description>
        <time_frame>up to 6 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin and Amoxicillin Placebo</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
          </group>
          <group group_id="O2">
            <title>Azithromycin + Amoxicillin</title>
            <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
          </group>
          <group group_id="O3">
            <title>Usual Care</title>
            <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Maternal Readmission</title>
          <description>Maternal readmission</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 6 weeks after delivery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Azithromycin and Amoxicillin Placebo</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.&#xD;
Azithromycin: Azithromycin tablet&#xD;
Placebo: Placebo tablet</description>
        </group>
        <group group_id="E2">
          <title>Azithromycin + Amoxicillin</title>
          <description>Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.&#xD;
Azithromycin and amoxicillin: azithromycin and amoxicillin</description>
        </group>
        <group group_id="E3">
          <title>Usual Care</title>
          <description>This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)&#xD;
Placebo: Placebo tablet</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="253"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alan Tita, MD</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>205-934-5612</phone>
      <email>atita@uab.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03248297
org study id: CHI UAB MISP # 54628
nct id: NCT03248297
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,
      Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or
      prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of
      azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal
      infectious outcomes and perinatal outcomes.
This 3-arm study is a large randomized clinical trial designed to evaluate the comparative
      effectiveness and safety of single dose oral azithromycin or combined
      azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and
      sepsis in laboring women. We have previously shown the effectiveness of azithromycin for
      extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for
      reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis
      from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at
      reducing these morbidities in women who have vaginal births. There is an increased risk of
      infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from
      our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery,
      we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or
      without oral amoxicillin) to prevent maternal peripartum infection and sepsis. This study,
      performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will
      randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor
      ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin,
      compared to usual care (placebo). Women will be followed to ascertain maternal infectious
      outcomes and perinatal outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Experienced Composite Peripartum Infection or Death
time frame: Up to 6 weeks after delivery
description: Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death
measure: Number of Participants Who Experienced Pyelonephritis
time frame: Up to hospital discharge
description: Other Infections
measure: Number of Participants Who Experienced Breast Infection
time frame: Up to 6 weeks after delivery
description: Other infections
measure: Number of Participants Who Experienced Other Infection
time frame: up to 6 weeks after delivery
description: Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria
measure: Number of Participants Who Experienced Fever
time frame: up to 6 weeks after delivery
description: Any fever higher than 38C
measure: Number of Participants Who Experienced Hypothermia
time frame: up to 6 weeks after delivery
description: Any hypothermia less than 36C
measure: Number of Participants Who Needed PP Antibiotic
time frame: up to 6 weeks after delivery
description: Any postpartum antibiotic
measure: Number of Participants Who Experienced Transfusion
time frame: up to 6 weeks after delivery
description: Blood transfusion
measure: Number of Participants Who Experienced Stillbirth
time frame: delivery
description: Any stillbirth
measure: Length of Stay
time frame: up to 6 weeks postpartum
description: Length of stay in days
measure: Number of Participants Who Experienced a Clinic Visit
time frame: up to 6 weeks after delivery
description: Clinic visit after discharge
measure: Number of Participants Who Experienced a Maternal Readmission
time frame: up to 6 weeks after delivery
description: Maternal readmission
arm group label: Azithromycin and amoxicillin placebo
arm group type: Experimental
description: Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.
arm group label: Azithromycin + amoxicillin
arm group type: Experimental
description: Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.
arm group label: Usual Care
arm group type: Placebo Comparator
description: This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)
intervention type: Drug
intervention name: Azithromycin
description: Azithromycin tablet
arm group label: Azithromycin and amoxicillin placebo
intervention type: Drug
intervention name: Azithromycin and amoxicillin
description: azithromycin and amoxicillin
arm group label: Azithromycin + amoxicillin
other name: azithromycin, amoxicillin
intervention type: Drug
intervention name: Placebo
description: Placebo tablet
arm group label: Azithromycin and amoxicillin placebo
arm group label: Usual Care
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alan Tita, MD, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: Cameroon
citation: Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
PMID: 10196487
citation: ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm. 1999 Sep 15;56(18):1839-88. doi: 10.1093/ajhp/56.18.1839. No abstract available.
PMID: 10511234
citation: Tita ATN, Boggess K, Saade G. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2017 Jan 12;376(2):182. doi: 10.1056/NEJMc1614626. No abstract available.
PMID: 28076707
citation: WHO. WHO recommendations for prevention and treatment of maternal peripartum infections. Sept 2015 http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines/en/
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Alan Tita
investigator title: Professor and Director
mesh term: Sepsis
mesh term: Puerperal Infection
mesh term: Endometritis
mesh term: Amoxicillin
mesh term: Azithromycin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 