<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/NCT03269188</url>
  </required_header>
  <id_info>
    <org_study_id>Persistent pain in C/S</org_study_id>
    <nct_id>NCT03269188</nct_id>
  </id_info>
  <brief_title>Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital</brief_title>
  <acronym>PPOPinC/S</acronym>
  <official_title>Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s 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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      prospective cohort study of women who underwent caesarean section in mulago hospital.&#xD;
      followed up for 2 months and assessed for development of persistent post operative pain at&#xD;
      the incision site and its effect on quality of life. incidence of persistent postoperative&#xD;
      pain and associated factors determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      prospective cohort study of 277 women who underwent caesarean section in mulago hospital.&#xD;
      demographic, medical history, intraoperative, postoperative details, and perioperative levels&#xD;
      of pain collected. followed up by telephone interviews for 2 months and assessed for&#xD;
      development of persistent post operative pain at the incision site and its effect on quality&#xD;
      of life. incidence of persistent postoperative pain and associated factors determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2016</start_date>
  <completion_date type="Actual">October 27, 2016</completion_date>
  <primary_completion_date type="Actual">October 10, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>persistent postoperative pain at caesarean section incision scar site.</measure>
    <time_frame>2 months.</time_frame>
    <description>participant report pain at site of caesarean section incision site scar at 2 months after caesarean section.</description>
  </primary_outcome>
  <enrollment type="Actual">277</enrollment>
  <condition>Chronic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        women scheduled to undergo both elective and emergency caesarean section in the obstetric&#xD;
        theatres of mulago national referral hospital during the study period and meet the&#xD;
        eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - ASA I, II, and III.&#xD;
&#xD;
          -  patient who has given informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have no telephone contact&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</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>Chronic Pain</mesh_term>
  </condition_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/NCT03269188
org study id: Persistent pain in C/S
nct id: NCT03269188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
prospective cohort study of women who underwent caesarean section in mulago hospital.
      followed up for 2 months and assessed for development of persistent post operative pain at
      the incision site and its effect on quality of life. incidence of persistent postoperative
      pain and associated factors determined.
prospective cohort study of 277 women who underwent caesarean section in mulago hospital.
      demographic, medical history, intraoperative, postoperative details, and perioperative levels
      of pain collected. followed up by telephone interviews for 2 months and assessed for
      development of persistent post operative pain at the incision site and its effect on quality
      of life. incidence of persistent postoperative pain and associated factors determined.
observational model: Cohort
time perspective: Prospective
measure: persistent postoperative pain at caesarean section incision scar site.
time frame: 2 months.
description: participant report pain at site of caesarean section incision site scar at 2 months after caesarean section.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Chronic Pain