<?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>IRCT2014041017212N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-16</date_registration>
      <primary_sponsor>DR Maryam Azizi</primary_sponsor>
      <public_title>Reduction of infection after caesarean section in obese women with antibiotic prophylaxis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between azithromycin and cephalexin for preventing infection after cesarean section in obese patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>222</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15882</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>Elective caesarean section in obese wemen.</hc_freetext>
      <i_freetext>Intervention 1: This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas,  Shariati Hospital was performed. The intervention group the same as control group received 2 g Keflin IV half an hour before surgery, and after surgery  cephalexin 500 mg P.O. every 6 hours for 48 hours with 250 mg azithromycin P.O. every 12 hours was prescribed for them. Intervention 2: This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas,  Shariati Hospital was performed. Control group received 2 g IV Keflin half hour before surgery for antibiotic prophylaxis and 48 hours after C/S, 500 mg every 6 hours cephalexin placebo and 250 mg azithromycin placebo was administered PO every 12 hours for them .</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 Abbasian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Shariati Hos., Shahid Naser Ave., Bandar Abbas</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7798 3769</telephone>
        <email>maryamabbasian@yahoo.comMaryam.abbasian@hums.ac.irsarahimi2000@yahoo.com</email>
        <affiliation>Dr. Shariati Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Shariati Hos., Shahid Naser Ave., Bandar Abbas</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 1333 2424</telephone>
        <email>maryam.azizikut@yahoo.com</email>
        <affiliation>Dr Shariati Hos.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this study, 222 pregnant women aged over 14 years; BMI&gt; 30; with a gestational age of 37 weeks or older; who are undergoing elective cesarean section; can be selected. Exclusion criteria included: pregnant women aged over 14 years; BMI&gt; 30; with a gestational age of 37 weeks or older; who are undergoing elective cesarean section with a history of diabetes; HTN; history of connective tissue diseases; and PROM; twin; antibiotics therapy  during recent weeks. Initially weight - height and BMI calculated and those with BMI&gt; 30 were selected and randomly divided into two groups. Both intervention group and control group in terms of demographic characteristics, duration of surgery, surgical techniques are the same.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other single delivery by caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas,  Shariati Hospital was performed. The intervention group the same as control group received 2 g Keflin IV half an hour before surgery, and after surgery  cephalexin 500 mg P.O. every 6 hours for 48 hours with 250 mg azithromycin P.O. every 12 hours was prescribed for them.</i_keyword>
      <i_keyword>This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas,  Shariati Hospital was performed. Control group received 2 g IV Keflin half hour before surgery for antibiotic prophylaxis and 48 hours after C/S, 500 mg every 6 hours cephalexin placebo and 250 mg azithromycin placebo was administered PO every 12 hours for them .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infection after surgery. Timepoint: after C/S, 1 week, 2 weeks, 3 weeks and 4 weeks after C/S. Method of measurement: Observe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>DR Maryam Azizi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-26</approval_date>
        <contact_name>Hormozgan University of Medical Siences</contact_name>
        <contact_address>ُShahid Naser Ave., Dr Shariati Hos., Bandar abbas Bandar Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
