<?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>IRCT201407115948N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Islamic Azad University of Karaj branch</primary_sponsor>
      <public_title>Effect  of heat therapy and cold therapy on delivery outcome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  the effect of two methods of heat therapy and cold therapy on labor pain and delivery outcome in primigravida women referred to the Karaj hospital in 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6426</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Out comes of delivery.</hc_freetext>
      <i_freetext>Intervention 1: In heat therapy group:in the first stage ,heat bag put in the low back(at least 1 hours) and the second stage put in perineum for 4 minutes. Intervention 2: In cold therapy  group:ice bag put in the low back for 10 minutes in the first stage and on perineum in the second stage. Intervention 3: In control group:routin management.</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>Soheila Moghimi Hanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Nursing &amp; midwifery faculty</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3418 2579</telephone>
        <email>soheila.moghimi@kiau.ac.irsomoghimi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Moghimi Hanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Nursing &amp; midwifery faculty</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3418 2579</telephone>
        <email>soheila.moghimi@kiau.ac.ir somoghimi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iinclusion criteria:female18-35,pregnant women in active phase of labor,cephalic persentation,primipara with 37-41week gestational age,singleton pregnancy&#13;
Exclusion criteria: cephalo pelvic disproportion,history of choronic pelvic pain, Use of any drug or method of analgesia and anesthesia, induction of labor with Oxytocin,complication of labor(cord prolaps,placenta abraptio,abnormal position),history of infertility, abnormal fetal heart patterns, presence of any special medical condition (e.g. chronic diseases) and use of narcotic drugs .</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>z-37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In heat therapy group:in the first stage ,heat bag put in the low back(at least 1 hours) and the second stage put in perineum for 4 minutes</i_keyword>
      <i_keyword>In cold therapy  group:ice bag put in the low back for 10 minutes in the first stage and on perineum in the second stage</i_keyword>
      <i_keyword>In control group:routin management</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: Dilation 3-4,6-7,9-10 cm. Method of measurement: McGill pain questionnaire.</prim_outcome>
      <prim_outcome>Duration of the first stage of labor. Timepoint: One time the start of labor until complete effacement and cervical dilatation. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
      <prim_outcome>Duration of the second stage of labor. Timepoint: One time from full dilatation of cervix to departure of baby. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
      <prim_outcome>Duration of the third stage of labor. Timepoint: One time from departure of baby to complete withdrawal of placenta. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: One time after departure of baby. Method of measurement: Observed as a vaginal delivery, instrumental delivery and cesarean section.</prim_outcome>
      <prim_outcome>Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Observation and examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fetal heart tone. Timepoint: Every half of time. Method of measurement: Sounic aid and digital clock.</sec_outcome>
      <sec_outcome>Perineal laceration. Timepoint: after delivery. Method of measurement: observation and examination.</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>Vice chancellor for research, Islamic Azad University of Karaj branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-12</approval_date>
        <contact_name>Ethics Committee of Islamic Azad university Karj barnch</contact_name>
        <contact_address>Crossroad of Moazen Blvd and Esteghlal Blvd, Rajaeeshahr, Karaj, Mailbox: 31485-313 Karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
