<?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>IRCT2017030432876N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-27</date_registration>
      <primary_sponsor>Vice chancellor for Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of theory-based educational intervention on behaviors of prenatal care</public_title>
      <acronym></acronym>
      <scientific_title>The effect of theory-based educational intervention on behaviors of prenatal care in pregnant women referred to health centers in Iranshahr</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25508</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Sample size was equal to 90 pregnant women that were selected based on simple random sampling and were assigned to intervention group (n=45) and control group (n=45) by the random number table.</study_design>
      <phase>2</phase>
      <hc_freetext>Prenatal care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group of this study consisted of 45 pregnant women of Iranshahr city which four the intervention group, four sessions of 60 minutes was hold  based on the theory (HBM and social support). Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants. Intervention 2: Control group of this study consisted of 45 pregnant women of Iranshahr city. Control group did not receive any intervention. Simultaneously with the intervention group, Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants.</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>Hossien Izadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Royan Alley, Keshavarz Blvd, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1415983341</zip>
        <telephone>+98 21 8801 3030</telephone>
        <email>hossien.izadirad@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University, Tehran, Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shamsoddin Niknami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 7, Jalal Al Ahmad Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115331</zip>
        <telephone>+98 218011001</telephone>
        <email>niknamis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were first pregnancy, wanted pregnancy, monogamy, aged between 18 and 35 years old, having health care records and gestational age less than 14 weeks; exclusion criteria included emigration, abortion, absence of the participants in the training sessions and require special care.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of normal first pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group of this study consisted of 45 pregnant women of Iranshahr city which four the intervention group, four sessions of 60 minutes was hold  based on the theory (HBM and social support). Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants.</i_keyword>
      <i_keyword>Control group of this study consisted of 45 pregnant women of Iranshahr city. Control group did not receive any intervention. Simultaneously with the intervention group, Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Susceptibility. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Perceived Severity. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Perceived Benefits. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Perceived Barriers. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Social support. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
      <prim_outcome>Prenatal care. Timepoint: Before the intervention, immediately after intervention, 3 and 6 months after the intervention. Method of measurement: Questionnaire Self-made.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Birth weight. Timepoint: After birth. Method of measurement: Scale.</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 Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-02</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>No 7, Jalal Al Ahmad Street, Tehran, Iran POST CODE 14115331 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
