<?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>IRCT2015061422720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-01</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jundishapur University of Medical  Sciences</primary_sponsor>
      <public_title>the effects of  health counseling on knowledge, attitude and choice of delivery mode</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of the effects of group and individual  health counseling on knowledge, attitude and choice of delivery mode in first pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization method: The names of eligible women by using closed envelopes placed in the bag, and are out of the bag equally and randomly,  and are divided  into two groups of separate and equally.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Awareness of the type of delivery. Condition 2: Attitude toward the type of delivery. Condition 3: Select the type of delivery.</hc_freetext>
      <i_freetext>Intervention 1: One group (group counseling)  received &#13;
choosing birth method counseling.For each group 8 sessions are regulated with 10 to 12 participating in each group . Each session takes 90 to 120 minutes. Each group will received consultation  once a week. Consultations is based on health counseling. Intervention 2: One group (individual counseling)  received choosing birth method counseling. for every participant  8 sessions are regulated. Each session takes 45 to 60 minutes. Each  person will received consultation  once a week. Consultations is based on health counseling.</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>Nosratabadi  Mahnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University city, Ahvaze</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>mahnaz.nosratabadi@gmail.ac.com; nosratabadi.m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hekmat  Khadija</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University city, Ahvaze</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>hekmat46@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : Iranian; At least primary school education;  First pregnancy;  Singleton pregnancy; gestational age between 20 to 26 weeks (based on the first day of the last normal menstruation); The applicant cesarean&#13;
&#13;
Exclusion criteria from the study : Highrisk pregnancy (preeclampsia , diabetes, uncontrolled gestational diabetes , a history of preterm delivery , intrauterine fetal death , etc); The history of infertility;  Prohibition of vaginal delivery for any reason;&#13;
without his consent or his wife to continue to participate in counseling sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
      <hc_code>-</hc_code>
      <hc_code>O83.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>Assisted single delivery, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>One group (group counseling)  received &#13;
choosing birth method counseling.For each group 8 sessions are regulated with 10 to 12 participating in each group . Each session takes 90 to 120 minutes. Each group will received consultation  once a week. Consultations is based on health counseling.</i_keyword>
      <i_keyword>One group (individual counseling)  received choosing birth method counseling. for every participant  8 sessions are regulated. Each session takes 45 to 60 minutes. Each  person will received consultation  once a week. Consultations is based on health counseling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge  of delivery mode. Timepoint: Before and one week after intervention the variable is measured . Method of measurement: Questionnaires to measure knowledge.</prim_outcome>
      <prim_outcome>Attitude toward the type of delivery. Timepoint: Before and one week after intervention the variable is measured . Method of measurement: Questionnaire measuring attitudes.</prim_outcome>
      <prim_outcome>Select  of delivery mode. Timepoint: Before and one week after intervention the variable is measured. Method of measurement: Questionnaires to measurement the  of delivery mode.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Natural or cesarean delivery. Timepoint: After intervention and childbirth. Method of measurement: Evaluation of individual medical records  or a hospital birth.</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, Ahvaz Jundishapur University of Medical  Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-30</approval_date>
        <contact_name>Ethics committee of Ahvaz JundiShapur University of Medical  Sciences</contact_name>
        <contact_address>University city, Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
