<?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>IRCT201106215525N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-27</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Cesarean rate reduction model</public_title>
      <acronym></acronym>
      <scientific_title>Designing of educational,financial and revisional interventions of human factors and structural  agents on cesarean rate reduction ,administration and evaluation of them in Shahroud and comparison with cesarean rate in adjucent cities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Factors influencing health status and contact with health services.</hc_freetext>
      <i_freetext>Intervention 1: Intervention in experiment group:&#13;
1- Prenatal educations mainly based on "Extended Parallel Process Model" are an essential intervention that will be given to 220 participants through 8 sessions. This Model discuss about fear incentive of  health threatening factor that in the present study includes fear from potential threats of unnecessary cesarean section. These educations will be presented by trained midwives in maternal health centers in Shahroud .Women in control group will be given prenatal routine care.&#13;
2- Instructions to obstetricians and midwives on the basis of confirmed context provided by The Ministry of Health and Medical Education &#13;
3- Revision of labor/delivery wards space in Shahroud hospitals in order to applying coping skills (relaxation, breathing and maternal position amending) to reduce pain and anxiety  during labor/delivery. &#13;
4- Increasing the fee for services of obstetricians, anesthesiologists and midwives in cases of vaginal delivery to avoiding unnecessary cesarean which may perform due to financial motivations. Intervention 2: Participants  in control group will not be educated likewise the intervention group on the basis of foregoing Model and will be given routine care.</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>Sepideh Hajian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reproductive Health Department, Shahroud University of Medical Sciences,7th Tir Sq., Shahroud, Iran</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 383 7649</telephone>
        <email>hajian74@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh  Hajian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reproductive Health Department, Shahroud University of Medical Sciences, 7th Tir Sq., Shahroud, Iran</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 27 3339 5054</telephone>
        <email>hajian74@yahoo.cm ; hajia@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: &#13;
 No history of former cesarean of uterine surgery,  general wellbeing with no indication for  medical/surgical  intervention ,  Persian literacy 4- singleton pregnancy and cephalic presentation , No scientific approved indication for cesarean surgery ,  Being at  18 gestational weeks , singleton pregnancy and cephalic presentation&#13;
Exclusion criteria conclude:&#13;
 Every induced systemic disease during present pregnancy which needs to medical or surgical intervention, and every obstetrical/non obstetrical indication for cesarean section</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of normal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention in experiment group:&#13;
1- Prenatal educations mainly based on "Extended Parallel Process Model" are an essential intervention that will be given to 220 participants through 8 sessions. This Model discuss about fear incentive of  health threatening factor that in the present study includes fear from potential threats of unnecessary cesarean section. These educations will be presented by trained midwives in maternal health centers in Shahroud .Women in control group will be given prenatal routine care.&#13;
2- Instructions to obstetricians and midwives on the basis of confirmed context provided by The Ministry of Health and Medical Education &#13;
3- Revision of labor/delivery wards space in Shahroud hospitals in order to applying coping skills (relaxation, breathing and maternal position amending) to reduce pain and anxiety  during labor/delivery. &#13;
4- Increasing the fee for services of obstetricians, anesthesiologists and midwives in cases of vaginal delivery to avoiding unnecessary cesarean which may perform due to financial motivations.</i_keyword>
      <i_keyword>Participants  in control group will not be educated likewise the intervention group on the basis of foregoing Model and will be given routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cesarean delivery. Timepoint: at the end of study. Method of measurement: calculating.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self efficacy. Timepoint: before and after prenatal educations. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Knowledge. Timepoint: before and after prenatal educations. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Intention. Timepoint: before and after prenatal educations. 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>Vice chancellor for research, Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-16</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, 7th Tir Sq, Sharoud, Iran Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
