<?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>IRCT20180928041164N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-13</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of electronic education of clinical management pregnant women during labor and postpartum on knowledge and clinical performance</public_title>
      <acronym></acronym>
      <scientific_title>Effect of electronic education of clinical management of substance dependent pregnant women during labor and postpartum on knowledge and clinical skill performance of midwives</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35113</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, in order to prevent the information leakage from the intervention group to the control group and not to alter the results of the study, at first, the pre-test and post-test of knowledge and clinical skills will be done in the control group, one month after posttest, knowledge and clinical retention test will be done and simultaneously with retention test in the control group, the pre-test will be performed in the intervention group and will be subjected to e-learning. Immediately after completing e-learning and one month after that, a post-test and retention test of knowledge and clinical skills will be taken from the intervention group. At the end of the study, the educational content is also available to the control group. Additionally, midwives who have completed the course with completion of the pre-test and post-test, and have at least a retraining score, will be awarded a Continuous Medical Education (CME), Randomization description: Random units are midwives, and the method is based on permuted random allocation. Using random block method and block size 4, and using the Random Allocation software has been developed by M. Saghaei) With a block size of four and twenty- five blocks (A total of 100 samples) A random list is generated And based on that list, Quadrilateral Blocks Combined, ABBA, BAAB, BABA, ABAB, BBAA, AABB Are produced And based on the combination obtained from 25 blocks.  Accordingly, midwives are assigned to the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Clinical management of substance dependent pregnant women during labor and postpartum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, a pre-test of knowledge and clinical performance will be performed from the intervention group, Then, the user code and password are provided for the samples to enter the Learning Management System (LMS). The intervention group will be trained for 3 weeks by 1 session of 1hour face to face and nine 40-minutes sessions of e-learning. Intervention 2: Control group: In the control group, without any intervention, three timed knowledge questionnaire and clinical performance using OSCE will be done.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is not more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasti Heidarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery Shiraz,  Namazi Square, Zand Blv.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>hastiheidarian@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roksana Janghorban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery Shiraz,  Namazi Square, Zand Blv.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>janghorban@sums.ac.ir</email>
        <affiliation>Shiraz 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>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least BSc degree in midwifery
Employment in Governmental Maternity Hospitals Affiliated to Shiraz University of Medical Sciences in Shiraz.
Researcher access to samples during the study period (For example, not having the intent of samples for unpaid or long-term leave).
Satisfaction to participate in the study and complete the informed written consent form
Having Internet access.
Have at least information for working with the computer to enter LMS.
Not participation in training courses associated with research title before starting the research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue to participate in research
Participate in other classes related to research title during the study period
Failure to study at least one of the content of e-learning in this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O99.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium</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: At first, a pre-test of knowledge and clinical performance will be performed from the intervention group, Then, the user code and password are provided for the samples to enter the Learning Management System (LMS). The intervention group will be trained for 3 weeks by 1 session of 1hour face to face and nine 40-minutes sessions of e-learning.</i_keyword>
      <i_keyword>Control group: In the control group, without any intervention, three timed knowledge questionnaire and clinical performance using OSCE will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Midwives Knowledge regarding Clinical management of substance dependent mothers during labor and post-partum period. Timepoint: Before the intervention, immediately after the end of the intervention. Method of measurement: A researcher-made questionnaire for measuring knowledge has 38 multiple choice questions.</prim_outcome>
      <prim_outcome>Midwives clinical performance on Clinical management of substance dependent mothers during labor and post-partum period. Timepoint: Before the intervention, immediately after the end of the intervention. Method of measurement: Objective Structured Clinical Exam (OSCE), made up of 5 stations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge Retention regarding on Clinical management of substance dependent mothers during labor and post-partum period. Timepoint: One month after intervention. Method of measurement: Researcher made questionnaire for knowledge assessment with 38 multiple choice questions.</sec_outcome>
      <sec_outcome>Clinical performance Retention regarding Clinical management of substance dependent mothers during labor and post-partum period. Timepoint: One month after intervention. Method of measurement: Researcher made questionnaire for knowledge assessment with 38 multiple choice questions.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-12</approval_date>
        <contact_name>ethic committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Flat 7, Shiraz University of Medical Sciences Building, Zand Blv. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
