<?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>IRCT138902222265N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-07-03</date_registration>
      <primary_sponsor>Deputy of research, Shahrekord University of Medical Sciences</primary_sponsor>
      <public_title>Comparing early initiation of oral feeding and Gum Chewing on the Return of Bowel Function in elective Cesarean-Delivery Patients in primiparous women, Hajar  hospitral, Shahrekord, 2007</public_title>
      <acronym></acronym>
      <scientific_title>Effect of early initiation of oral feeding and Gum Chewing on the Return of Bowel Function in elective Cesarean-Delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1897</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ileus.</hc_freetext>
      <i_freetext>Intervention 1: Routine post-op care: in control group after the appearance of bowel sounds oral hydration started and then a gradual shift to the regular diet was adopted. Intervention 2: patient in the gum chewing group chewed sugarless gum one stick 4 times per day as soon as they recovered from anesthesia till the time they passed flatus or defected. Intervention 3: Oral hydration started with sips of Juice or tea 4-h postsurgury irrespective of presence of bowel sounds. soft diet was started after bowel sounds was appeared.</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>Faranak   Safdari Decheshmeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 1333 5648</telephone>
        <email>faranaksafdari@gmail.com</email>
        <affiliation>Shahrekord University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faranak Safdari Decheshmeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery and Nursing Department, Shahrekord University of Medical Sciences, Rahmatie</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 38 1333 5648</telephone>
        <email>faranaksafdari@gmail.com</email>
        <affiliation>Shahrekord University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Uncomplicated term singleton pregnancies undergoing a planned caesarean section performed under regional anaesthesia and by an gynecologist, transverse (horizontal) incision, At least NPO for 8 hour before surgery, Received the maximum four doses of antibiotic prophylaxis, &#13;
Exclusions criteria: History of abdominal surgery or cesarean section, preeclampsia, diabetes, heart disease, being at risk for incidence of aspiration or ileuses, postoperative complications such as uterine atonia, intra operative complications such as severe adhesions and blood transfusion during surgery, surgery lasted more than 90 minutes, discharged with personal willing despite physician’s decision, intolerance liquid diet, presence of nausea and vomiting, receiving magnesium sulfate, history of malignancy, obstructive or inflammatory bowel diseases and injuries, excessive bowel manipulation, inability to chew gum.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k00, k93, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the digestive system, Paralytic ileus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Routine post-op care: in control group after the appearance of bowel sounds oral hydration started and then a gradual shift to the regular diet was adopted</i_keyword>
      <i_keyword>patient in the gum chewing group chewed sugarless gum one stick 4 times per day as soon as they recovered from anesthesia till the time they passed flatus or defected.</i_keyword>
      <i_keyword>Oral hydration started with sips of Juice or tea 4-h postsurgury irrespective of presence of bowel sounds. soft diet was started after bowel sounds was appeared</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Flatus passing. Timepoint: Every hour. Method of measurement: Asking from patients.</prim_outcome>
      <prim_outcome>Gas passing. Timepoint: Every hour. Method of measurement: Asking from patients.</prim_outcome>
      <prim_outcome>Hearing bowel sound. Timepoint: Every hour. Method of measurement: Hearing of bowel sound by stetoscope.</prim_outcome>
      <prim_outcome>Sensation of bowel movement. Timepoint: Every hour. Method of measurement: Asking from patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>NAUSEA. Timepoint: PER ONE HOUR. Method of measurement: QUESITION FROM PATIENT.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Every hour. Method of measurement: Asking from patients.</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>Deputy of research, Shahrekord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-02-20</approval_date>
        <contact_name>Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Shahrekord University of Medical Sciences, Rahmatie, Shahrekord Shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
