<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2014041017211N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-05</date_registration>
      <primary_sponsor>Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.</public_title>
      <acronym></acronym>
      <scientific_title>Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>424</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15881</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>To prevent post C/S infection.</hc_freetext>
      <i_freetext>Intervention 1: Control Group received Cephalotin 2gr IV and placebo 1gr oral. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.&#13;
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients. Intervention 2: Case group received Azithromycin and Cephalotin as a preoperative antibiotic prophylaxis. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.&#13;
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Abassian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Intersection of Shahid Motahari avenue; Shahid Nacer BLVD</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 1333 2155</telephone>
        <email>maryam.abbasian@hums.ac.ir</email>
        <affiliation>Dr. Shariati Hospital, Hormozgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Intersection of Shahid Motahari avenue; Shahid Nacer BLVD</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 1333 2155</telephone>
        <email>mazizi@hums.ac.ir</email>
        <affiliation>Dr. Shariati Hospital, Hormozgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The single most important risk factor for postpartum maternal infection is cesarean section. Women undergoing cesarean section have greater risk for infection and infectious morbidity compared with a vaginal birth. The objective of this study is to determine if extended spectrum prophylactic antibiotic treatment (cefazolin and azithromycin) reduces post-cesarean delivery infections.&#13;
Inclusion: spontaneously labor or induced labor; rupture of membranes within 4 hour prior the termination; meconium passage before section and non-cephalic presentation.&#13;
Exclusion: diabetes; multiple Pregnancy; patients who have contraindication to receive antibiotics; history of Azitromycine or Erythromicine used in one last week; clinical finding about corioamniotitis; pulmonary edema; immunosupretion; Aids; patients who could not follow up after Cesarean section; significant renal disease; preeclampsia; rapture of membrane more than 18 hour.              &#13;
 This randomized controlled double blind clinical trial was done on 424 women over 14 year with gestational age more than 24 week who underwent non- elective cesarean in Shariati Hospital in Bandar Abbas during 2011 July until 2012 August.&#13;
Patients randomly divided to case and control group. Keflin 2 gram Intera Venus was prescribed 0.5 hour before surgery for both case and control groups. Cases also received azithromycin 1 gram oral 0.5 hour before surgery. Patients were under observed till 1 month after surgery. Fever; open wound; endometritis and hospitalization were compared between two groups.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>082.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by emergency caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group received Cephalotin 2gr IV and placebo 1gr oral. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.&#13;
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients.</i_keyword>
      <i_keyword>Case group received Azithromycin and Cephalotin as a preoperative antibiotic prophylaxis. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.&#13;
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: After intervention. Method of measurement: Thermometer in degrees Celsius.</prim_outcome>
      <prim_outcome>Endometritis. Timepoint: After intervention. Method of measurement: Based on clinical symptoms such as fever, malodorous discharge and uterine tenderness.</prim_outcome>
      <prim_outcome>Wound infection. Timepoint: After intervention. Method of measurement: Number of open stitches.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of stay. Timepoint: After intervention. Method of measurement: Days of hospitalization after surgery.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-27</approval_date>
        <contact_name>Vice Chancellor for Research and Technology Hormozgan University of Medical Sciences, Bandar Abbas, </contact_name>
        <contact_address>East side of Shahid Mohammadi Hospital, Islamic Republic of Iran BLVD Bandar Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
