<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/NCT03007706</url>
  </required_header>
  <id_info>
    <org_study_id>MiniaMUH</org_study_id>
    <nct_id>NCT03007706</nct_id>
  </id_info>
  <brief_title>Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery</brief_title>
  <official_title>Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raghda Gamal Mohamed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia Maternity University Hospital</source>
  <brief_summary>
    <textblock>
      This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics&#xD;
      given to women undergoing a cesarean section for reducing the incidence of postpartum&#xD;
      infectious morbidity and to assess potential maternal adverse effects and any impact on the&#xD;
      infant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity</measure>
    <time_frame>2 weeks following cesarean section</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Postpartum Infectious Morbidity in Cesarean Section Delivery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Women undergo cesarean section delivery</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women undergo cesarean section delivery whether elective or emergency&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women undergoing cesarean delivery, both elective and non-elective.&#xD;
&#xD;
          2. Rupture of membranes and labor contractions will be allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unknown outcome from the patient.&#xD;
&#xD;
          2. Refusing to participate in the study from the admission conse&#xD;
&#xD;
          3. Allergy to antibiotics.&#xD;
&#xD;
          4. Any visible infection.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Minia Maternity University Hospital</investigator_affiliation>
    <investigator_full_name>Raghda Gamal Mohamed</investigator_full_name>
    <investigator_title>Minia university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</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/NCT03007706
org study id: MiniaMUH
nct id: NCT03007706
lead sponsor: 
This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics
      given to women undergoing a cesarean section for reducing the incidence of postpartum
      infectious morbidity and to assess potential maternal adverse effects and any impact on the
      infant.
observational model: Case-Only
time perspective: Prospective
measure: role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity
time frame: 2 weeks following cesarean section
intervention type: Procedure
intervention name: Women undergo cesarean section delivery
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Minia Maternity University Hospital
investigator full name: Raghda Gamal Mohamed
investigator title: Minia university
mesh term: Communicable Diseases
mesh term: Infections