<?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>IRCT2014050411360N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-11</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evidence Based Labor and Normal Delivery Management: &#13;
A Mixed Methods Study</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of implementation of evidence based clinical practices on mother and newborn outcomes during normal labor and delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11626</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The subjects in this group will receive evidence based care during normal labor and delivery. Intervention 2: Control group: This group will be received routine care of hospital during normal labor and delivery.</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>Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Isfahan University of Medical Sciences,  Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1668 7153</telephone>
        <email>minairavani2004@yahoo.com; minairavani2004@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences, Nursing and Midwifery School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Iravani, Dr. Elahe Zarean, Dr.Mohsen Janghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.  Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran-Department of Epidemiology, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8144503500</zip>
        <telephone>+98 31 1792 2774</telephone>
        <email>minairavani2004@yahoo.com; minairavani2004@ gmail.com; zarean.elahe@gmail.com; zarean@med.mui.ac.ir;</email>
        <affiliation>Isfahan University of Medical Sciences,Isfahan,iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: intend to participation in study; low risk pregnant women; maternal age 18-35 years old; single pregnancy; gestational age 38-42 weeks; vertex presentation; spontaneous labor pain; vaginal dilatation between 3 and 4 centimeter; mother BMI 19.8-26 kg/m2; estimated fetal weight 2500-4000 gr. &#13;
Exclusion criterion: unwillingness or reject of participation in study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single spontaneous delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The subjects in this group will receive evidence based care during normal labor and delivery</i_keyword>
      <i_keyword>Control group: This group will be received routine care of hospital during normal labor and delivery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of active phase and second stage of labor. Timepoint: Cervix dilatation from 4 centimeter to 10 centimeter for active phase of labor and cervix dilatation from 10 centimeter  to delivery of newborn for second stage of labor. Method of measurement: Clinical examination/ Measurement by digital chronometer / record in check list.</prim_outcome>
      <prim_outcome>Labor Pain intensity. Timepoint: Measurement severity of pain during first and second stage of labor. Method of measurement: By visual analog scale/ record in check list.</prim_outcome>
      <prim_outcome>Frequency use of oxytocin during normal labor. Timepoint: During first and second stage of normal labor. Method of measurement: Observation / record in check list.</prim_outcome>
      <prim_outcome>Frequency use of routine episiotomy. Timepoint: Before of delivery. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Post partum hemorrhage. Timepoint: After childbirth. Method of measurement: Measurement  of HG and HCT level by blood sampling 12 and 24 h after childbirth.</prim_outcome>
      <prim_outcome>Spontaneous tears in perinea and vagina. Timepoint: After of delivery. Method of measurement: Observation / clinical examination/ record in check list.</prim_outcome>
      <prim_outcome>Method of delivery. Timepoint: After of delivery. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Mother’s satisfaction of delivery. Timepoint: Before discharging of hospital. Method of measurement: Macky satisfaction questionnaire.</prim_outcome>
      <prim_outcome>Apgar score. Timepoint: 1 and 5 minute after of delivery. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Frequency newborn admission to neonatal ward or NICU. Timepoint: After of delivery. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Breast feeding during 30  min after birth. Timepoint: during30  min after birth. Method of measurement: Observation and record in check list.</prim_outcome>
      <prim_outcome>Average time of admission to discharge of mother. Timepoint: Of admission time to discharge. Method of measurement: Measurement by Digital chronometer / record in check list.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-12</approval_date>
        <contact_name>Ethics Committee of the Isfahan University of Medical Sciences</contact_name>
        <contact_address>Research Dupty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
