<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/NCT03822039</url>
  </required_header>
  <id_info>
    <org_study_id>2018-085</org_study_id>
    <nct_id>NCT03822039</nct_id>
  </id_info>
  <brief_title>WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital</brief_title>
  <official_title>Compliance Levels With WHO Checklist-based Infection Prevention Guidelines and Associated Surgical Site Infection Following Caesarean Delivery in Mulago Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective cohort study will assess all mothers undergoing elective and emergency&#xD;
      caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based&#xD;
      temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over&#xD;
      a period of 3 months and follow-up daily until discharge or 30 days .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the level of compliance with WHO checklist-based infection prevention guidelines&#xD;
      following caesarean delivery in Mulago National Referral Hospital, Kawempe.&#xD;
&#xD;
      To determine the association between compliance with WHO checklist-based infection prevention&#xD;
      guidelines and surgical site infection following caesarean delivery in Mulago Hospital,&#xD;
      Kawempe.&#xD;
&#xD;
      This prospective cohort study will assess all mothers undergoing elective and emergency&#xD;
      caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based&#xD;
      temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over&#xD;
      a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for&#xD;
      the purpose of documentation of surgical site infection. Data will be collected using the&#xD;
      checklist expansion for antisepsis and infection control questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 16, 2018</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe</measure>
    <time_frame>24Hours</time_frame>
    <description>Using a tool of 12 parameters from the WHO Surgical Safety Checklist-based infection prevention standards, each of the parameters will be given a score of 1 if it was obeyed by the respondent and a score of 0 if it was omitted. Compliance will be then expressed as a percentage completion of the items comprising the checklist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>surgical site infection within 30 days of operation</measure>
    <time_frame>30 days</time_frame>
    <description>Patients will be directly followed up during ward rounds until discharge and thereafter, telephone calls will be used every four days to enquire for development of surgical site infections such as fever, foul-smelling wound, redness around the incision, swelling/ induration at the wound site, burst wound.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">768</enrollment>
  <condition>Surgical Site Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe&#xD;
        labour suite and gynaecology theatre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers undergoing elective and emergency caesarean deliveries in Mulago National&#xD;
             Referral Hospital, Kawempe in labour suite and gynaecology theatre.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is unconscious and unknown patient&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Anne Mbiya, Mbchb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makerere University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Mbiya, Mbchb</last_name>
    <phone>0782423389</phone>
    <phone_ext>256</phone_ext>
    <email>mbiyaanne2@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ponsiano Ocama, Phd</last_name>
    <phone>0772421190</phone>
    <phone_ext>256</phone_ext>
    <email>ponsiano.ocama@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mulago hospital</name>
      <address>
        <city>Kampala</city>
        <state>Mulago Hospital</state>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ponsiano Ocama, PHD</last_name>
      <phone>0772421190</phone>
      <phone_ext>256</phone_ext>
      <email>Ponsiano.ocama@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</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/NCT03822039
org study id: 2018-085
nct id: NCT03822039
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective cohort study will assess all mothers undergoing elective and emergency
      caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based
      temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over
      a period of 3 months and follow-up daily until discharge or 30 days .
To determine the level of compliance with WHO checklist-based infection prevention guidelines
      following caesarean delivery in Mulago National Referral Hospital, Kawempe.

      To determine the association between compliance with WHO checklist-based infection prevention
      guidelines and surgical site infection following caesarean delivery in Mulago Hospital,
      Kawempe.

      This prospective cohort study will assess all mothers undergoing elective and emergency
      caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based
      temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over
      a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for
      the purpose of documentation of surgical site infection. Data will be collected using the
      checklist expansion for antisepsis and infection control questionnaire.
observational model: Cohort
time perspective: Prospective
measure: Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe
time frame: 24Hours
description: Using a tool of 12 parameters from the WHO Surgical Safety Checklist-based infection prevention standards, each of the parameters will be given a score of 1 if it was obeyed by the respondent and a score of 0 if it was omitted. Compliance will be then expressed as a percentage completion of the items comprising the checklist.
measure: surgical site infection within 30 days of operation
time frame: 30 days
description: Patients will be directly followed up during ward rounds until discharge and thereafter, telephone calls will be used every four days to enquire for development of surgical site infections such as fever, foul-smelling wound, redness around the incision, swelling/ induration at the wound site, burst wound.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: N/A
last name: Anne Mbiya, Mbchb
role: Principal Investigator
affiliation: Makerere University
last name: Anne Mbiya, Mbchb
phone: 0782423389
phone ext: 256
email: mbiyaanne2@gmail.com
last name: Ponsiano Ocama, Phd
phone: 0772421190
phone ext: 256
email: ponsiano.ocama@gmail.com
facility: 
status: Recruiting
contact: 
country: Uganda
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
sharing ipd: No