<?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>IRCT2017083131117N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-27</date_registration>
      <primary_sponsor>vice chancellor for research of Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of education on  women's knowledge, attitude and decision making toward childbearing</public_title>
      <acronym>-</acronym>
      <scientific_title>Effect of Trans- theoretical model-based education on reproductive age women's knowledge, attitude and decision making toward childbearing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: table of random number will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>childbearing.</hc_freetext>
      <i_freetext>Intervention 1: The control group: This group will receive common education for promoting childbearing on the basis of new population policies in accordance with the Ministry of Health's instructions from the relevant center along with the intervention group. Intervention 2: The intervention group: This group will receive training in accordance with their behavioral stages: 2 sessions of the precontemplation group (with topics: importance of childbearing in sociology, awareness of childbearing and the consequences of delay, discontinuation of contraceptive methods, healthy lifestyle before pregnancy), 2 sessions of the contemplation group (with topics: Interruption of contraceptive methods, healthy lifestyle, preconception counseling), and 1 session of the preparation group (with topics preconception counseling, embryo developmental stages, maternal health and discussion of teratogens, pregnancy symptoms and how to deal with it, importance of embryo screening during pregnancy, proper pregnancy care for childbearing), with various method such as lecture with slide show, question and answer, video, small group meetings. Each session will be 60 minutes long. At the end of each session a pamphlet summarizing its educational materials session will provide. After the completion of the training program, text messages will be provided on a weekly basis. In case of need, the test group can receive telephone or textual advice.</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>Dr Soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3335 8918</telephone>
        <email>s.khani@mazums.ac.ir, khanisog343@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences, Sexual and Reproductive Health Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3336 8918</telephone>
        <email>s.khani@mazums.ac.ir, khanisog343@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Marriage; living with husband; aged 18 to 35; fertility; having a maximum of 2 children; having passed at least one year of marriage; using a contraceptive method; interval between pregnancy more than 3 years; lack of planning for the current or future pregnancy despite the desire to have a child; access to the mobile phone; to be in pre-contemplation, contemplation and preparation groups based on trans-theoretical model.&#13;
Exclusion criteria: absence in the first training session; unwillingness of woman or her husband to participate in a research project; infertility; severe family conflicts; more than 3 times cesarean section; certain chronic diseases and any prohibition of childbearing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group: This group will receive common education for promoting childbearing on the basis of new population policies in accordance with the Ministry of Health's instructions from the relevant center along with the intervention group.</i_keyword>
      <i_keyword>The intervention group: This group will receive training in accordance with their behavioral stages: 2 sessions of the precontemplation group (with topics: importance of childbearing in sociology, awareness of childbearing and the consequences of delay, discontinuation of contraceptive methods, healthy lifestyle before pregnancy), 2 sessions of the contemplation group (with topics: Interruption of contraceptive methods, healthy lifestyle, preconception counseling), and 1 session of the preparation group (with topics preconception counseling, embryo developmental stages, maternal health and discussion of teratogens, pregnancy symptoms and how to deal with it, importance of embryo screening during pregnancy, proper pregnancy care for childbearing), with various method such as lecture with slide show, question and answer, video, small group meetings. Each session will be 60 minutes long. At the end of each session a pamphlet summarizing its educational materials session will provide. After the completion of the training program, text messages will be provided on a weekly basis. In case of need, the test group can receive telephone or textual advice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Childbearing knowledge toward childbearing. Timepoint: Before the intervention, 3 and 6 months after the completion of the educational intervention. Method of measurement: validated Researcher-made questionnaire on childbearing.</prim_outcome>
      <prim_outcome>Childbearing attitude toward childbearing. Timepoint: before the intervention, 3 and 6 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stages of behavior change construct. Timepoint: Before the intervention, 3 and 6 months after the completion of the educational intervention. Method of measurement: Decision-making questionnaire for childbearing based on a trans-theoretical model (Dr. Abolhassan Naghibi).</sec_outcome>
      <sec_outcome>Self efficacy construct. Timepoint: before the intervention, 3 and 6 months after intervention. Method of measurement: decision making about childbearing questionnaire.</sec_outcome>
      <sec_outcome>Decision making about childbearing construct. Timepoint: before the intervention, 3 and 6 months after intervention. Method of measurement: decision making about childbearing 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 of Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-13</approval_date>
        <contact_name>ٍEthics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>vice chancellor for research, Mazandaran University of Medical Sciences, Moalem Square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
