<?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>IRCT2015052020706N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-29</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahroud University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Effect of rereading of written scenario on selection of delivery method</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of comparing effectiveness of "rereading of written scenario" and "theory of planned behavior" with a group without any intervention on selection of delivery method in nulliparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>213</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization done through (http://graphpad.com/quickcalcs/randomize1.cfm).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: The control group received no intervention. This group includes 71 nulliparous pregnant women. &#13;
The delivery type inventory according to theory of planned behavior and also pregnancy self-efficacy scale questionnaire is completed by them once during 28-32th weeks and for the second time at 37-40th weeks of pregnancy. Intervention 2: The first  intervening group (rereading of written scenarios based on the theory of planned behavior) comprises of 71 nulliparous pregnant women, who receive 3 sessions of 120 minutes with sequence of once a week during28-32th week pregnancy with written scenarios and  educational aids manual about benefits of normal labor and non-pharmacological methods of pain relief. Intervention 3: The second intervening group (theory of planned behavior group) comprises of 71 nulliparous pregnant women, who receive 3 sessions of 120 minutes with sequence of once a week during28-32th week pregnancy with educational aids manual about benefits of normal labor and non-pharmacological methods of pain relief.</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>Massome Rasoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences and Health Services , 7 Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>massomerasoli@shmu.ac.irmassomerasoli@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mirrezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical sciences and Health, 7 Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>mirrezaie78@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Primigravida; pregnancy age:28-32 weeks; age of mother: 18-35 years; singleton pregnancy, having educational degree higher than a fifth grade of primary school, lack of repeated miscarriages, placenta previa and a ban on normal childbirth,  lack of history for mental and physical diseases, non- smoking and drug abuse. Exclusion criteria: Those women will be excluded who do not tend to participate in educational classes, are absent in any of sessions of consultation, are not threatened by risk factors such as being conflicted with preeclampsia and preterm delivery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80, O82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single spontaneous delivery, Single delivery by caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group received no intervention. This group includes 71 nulliparous pregnant women. &#13;
The delivery type inventory according to theory of planned behavior and also pregnancy self-efficacy scale questionnaire is completed by them once during 28-32th weeks and for the second time at 37-40th weeks of pregnancy.</i_keyword>
      <i_keyword>The first  intervening group (rereading of written scenarios based on the theory of planned behavior) comprises of 71 nulliparous pregnant women, who receive 3 sessions of 120 minutes with sequence of once a week during28-32th week pregnancy with written scenarios and  educational aids manual about benefits of normal labor and non-pharmacological methods of pain relief.</i_keyword>
      <i_keyword>The second intervening group (theory of planned behavior group) comprises of 71 nulliparous pregnant women, who receive 3 sessions of 120 minutes with sequence of once a week during28-32th week pregnancy with educational aids manual about benefits of normal labor and non-pharmacological methods of pain relief.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delivery mode. Timepoint: After intervention and Immediately after delivery. Method of measurement: Percent.</prim_outcome>
      <prim_outcome>Childbirth Self-Efficacy. Timepoint: before the intervention at 28-32 weeks and after the intervention at 37-40 weeks of pregnancy. Method of measurement: childbirth self-efficacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score of knowledge. Timepoint: before the intervention at 28-32th week of pregnancy  and after the intervention at 37-40th week of pregnancy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The  scores of attitude. Timepoint: before the intervention at 28-32th week of pregnancy  and after the intervention at 37-40th week of pregnancy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The scores of Perceived behavioral control. Timepoint: before the intervention at 28-32th week of pregnancy  and after the intervention at 37-40th week of pregnancy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The scores of Subjective norms. Timepoint: before the intervention at 28-32th week of pregnancy  and after the intervention at 37-40th week of pregnancy. 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 and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-13</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences.</contact_name>
        <contact_address>Shahroud University of Medical sciences and Health,  7 Tir Square, Shahroud Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
