<?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>IRCT2013082614486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-28</date_registration>
      <primary_sponsor>Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica</primary_sponsor>
      <public_title>The effect of selective production base on  Carum carvi on early return of bowel motility after caesarean section</public_title>
      <acronym>The effect of Carum carvi</acronym>
      <scientific_title>The effect of selective production base on  Carum carvi on early return of bowel motility after caesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Questionnaire by a person who is unaware of the grouping of the subjects will be completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative intestinal obstruction.</hc_freetext>
      <i_freetext>Intervention 1: This study will be done on 90 women from the 22 December 2013 to 21 March 2014 at the Emam khomeini Hospital in Sari will be delivered by cesarean section .Intervention  Group are consisted of 45 cases that drink 20 ml of the syrup that has 2 mg of Carum Carvi  in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list. Intervention 2: Control group are consisted of 45 cases that drink 20 ml of the placebo in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list.</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>Seyde Sedighe Yosefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behesht Ave., Vahdat eslami St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818786481</zip>
        <telephone>+98 15 1325 4066</telephone>
        <email>dr_ssyosefi@yahoo.com; s-yousefi@sina.tums.ac.ir</email>
        <affiliation>Traditional Medicine Faculty, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnaz Sohrabvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Keshavar Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2741</telephone>
        <email>fsohrabvand@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: fasting for at least 8 hours before surgery; received a maximum of 4 doses of intravenous antibiotics; having a gestational age of 42-38 weeks; having good vital signs; no unusual complications of surgery; absence of fever before operation; lack of medical disorders and obstetric patients addicted to cigarettes and illegal drugs are not. Exclusion criteria: the patient withdrew from the study, those at risk for ileus and aspiration ( background radiation , anastomotic stricture , peptic ulcer, esophagitis, intestinal obstruction ), a lot of individuals taking sedatives, obstetric complications such as fatty liver of pregnancy, preeclampsia, diabetes, placental abruption, chorioamnionitis, post-operative complications ( atonic uterus, antibiotic therapy, more than four doses ), intraoperative complications ( severe adhesion, blood transfusion, injury to bowel and bladder ), personal discharge, during over 90 minutes, the use of magnesium sulfate for the possibility of nausea, infection, hypothyroidism, hyperparathyroidism, neuromuscular disease, excessive intestinal manipulation is obvious.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K91.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postoperative intestinal obstruction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study will be done on 90 women from the 22 December 2013 to 21 March 2014 at the Emam khomeini Hospital in Sari will be delivered by cesarean section .Intervention  Group are consisted of 45 cases that drink 20 ml of the syrup that has 2 mg of Carum Carvi  in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list.</i_keyword>
      <i_keyword>Control group are consisted of 45 cases that drink 20 ml of the placebo in two half-hour interval, 6 hours after surgery. This group will be observed under the routine care after cesarean. Thus, their feeding will be started after bowel sounds auscultation and flatus, with clear liquid. Soft and normal diet will be started after defecation. We have to check the sounds of bowel every 30 minutes until it will be heard, the time to the first passage of flatus and defecation and bowel motility and Coming down from the bed and the time until the discharge from the hospital will be completed by patient in a special check list.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bowel sound. Timepoint: Each half-hour intervals , one hour after the intervention until the first sound will be heard. Method of measurement: Bowel sound auscultation by Stethoscope.</prim_outcome>
      <prim_outcome>Flatus. Timepoint: First flatus. Method of measurement: Check list.</prim_outcome>
      <prim_outcome>Defecation. Timepoint: The first defecation after caesarean. Method of measurement: Check list.</prim_outcome>
      <prim_outcome>The time of discharge. Timepoint: At discharge. Method of measurement: Check list or file.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bloat. Timepoint: Befor and after intervention. Method of measurement: Questionnaire.</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. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-27</approval_date>
        <contact_name>Ethics Committee, Faculty of Traditional Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Islamic Medicinal Research Institute, Pirnia Ave., Lalehzar St., Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
